
Regulatory Intelligence
Navigate the Regulatory Landscape and Make Smart Decisions
Stay current with ever-changing regulations, with routine updates from ClinChoice. Use the reference chart below to follow regulatory updates on a variety of medical topics from health authorities and countries worldwide. Have questions or want to talk to an expert? Contact us to schedule a consultation.

Country/Region | Health Authority | Date of Publishing | Product Type | Topic | Domain | URL |
---|---|---|---|---|---|---|
USA | Food and Drug Administration | 3-4-23 | Medical Device | Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions (draft guidance | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-4-23 | Drug | Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Regulatory | Visit Page |
Japan | Pharmaceuticals and Medical Devices Agency | 3-4-23 | Drug | Ministerial Ordinance on Good Clinical Practice for Drugs | Clinical | Visit Page |
USA | Food and Drug Administration | 3-4-23 | Drug | Mpox: Development of Drugs and Biological Products (draft guidance) | Clinical | Visit Page |
USA | Food and Drug Administration | 30-3-23 | Medical Device | Medical Device Development Tools (MDDT) | Regulatory | Visit Page |
USA | Food and Drug Administration | 30-3-23 | Medical Device | Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act | Regulatory | Visit Page |
USA | Food and Drug Administration | 29-3-23 | Medical Device | Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions (draft guidance) | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 28-3-23 | Medical Device | Extension of CE certificates | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-3-23 | Medical Device | General Considerations for Animal Studies Intended to Evaluate Medical Devices | Safety | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 27-3-23 | Medical Device | Findings on manufacturers failing to meet post market surveillance requirements | Regulatory | Visit Page |
USA | Food and Drug Administration | 27-3-23 | Drug | Update on In-Person Face-to-Face ANDA Meetings | Regulatory | Visit Page |
USA | Food and Drug Administration | 27-3-23 | Drug | Clinical trial considerations to support accelerated approval of oncology therapeutics (draft guidance) | Clinical | Visit Page |
USA | Food and Drug Administration | 27-3-23 | Medical Device | Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | Regulatory | Visit Page |
USA | Food and Drug Administration | 27-3-23 | Medical Device | Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 24-3-23 | Drug | TGA’s new powers will help reduce the impact of medicine shortages on patients | Regulatory | Visit Page |
Malaysia | Medical Device Authority | 23-3-23 | Medical Device | Withdrawal of medical device registration (new and re-register) and change of notification application | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 21-3-23 | Drug | Consultation outcome - Government response to consultation on legislative proposals for clinical trials | Clinical | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 21-3-23 | Drug | MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years | Clinical | Visit Page |
Australia | Therapeutic Goods Administration | 20-3-23 | Drug | GMP Clearance: Additional countries added to MRA pathway | Regulatory | Visit Page |
UK | Medicines | 20-3-23 | Medical Device | Request for an update of the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties | Safety | Visit Page |
USA | Food and Drug Administration | 20-3-23 | Medical Device | Send and Track Medical Device Premarket Submissions Online: CDRH Portal | Regulatory | Visit Page |
Malaysia | National Pharmaceutical Regulatory Agency | 17-3-23 | Drug | Topiramate: Neurodevelopmental disorders in children exposed to topiramate during pregnancy | Regulatory | Visit Page |
Argentina | ANMAT | 16-3-23 | Drug | ANMAT signed a Memorandum of Understanding with the United States Pharmacopoeia | Regulatory | Visit Page |
USA | Food and Drug Administration | 16-3-23 | Drug | Pharmacogenomic Data Submissions (draft guidance) | Regulatory | Visit Page |
Malaysia | National Pharmaceutical Regulatory Agency | 13-3-23 | Drug | Declaration of Worldwide Registration Status for Generic Medicines in QUEST System | Regulatory | Visit Page |
USA | Food and Drug Administration | 10-3-23 | Drug | Evaluation of Gastric pH Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications | Clinical | Visit Page |
Europe | European Medicines Agency | 9-3-23 | Drug | Guideline on computerized systems and electronic data in clinical trials | Regulatory | Visit Page |
Malaysia | Medical Device Authority | 8-3-23 | Medical Device | Classification of rehabilitation, physiotherapy, and speech therapy device | Regulatory | Visit Page |
Europe | European Medicines Agency | 8-3-23 | Medical Device | Amendment of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (MDR) | Regulatory | Visit Page |
Europe | European Medicines Agency | 8-3-23 | Medical Device | Amendment of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (IVDR) | Regulatory | Visit Page |
Europe | European Medicines Agency | 7-3-23 | Medical Device | Council takes action to mitigate risk of medical devices shortage y extending the MDR deadlines | Regulatory | Visit Page |
Europe | European Medicines Agency | 7-3-23 | Drug | Questions and Answers about the raw data proof-of-concept pilot for industry | Clinical | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 7-3-23 | Medical Device | https://www.gov.uk/government/news/windsor-framework-unveiled-to-fix-problems-of-the-northern-ireland-protocol | Regulatory | Visit Page |
USA | Food and Drug Administration | 7-3-23 | Drug | Nitrosamine Impurities: Latest USP Tool Further Aids Understanding and Control | Regulatory | Visit Page |
The Philippines | Philippines FDA | 6-3-23 | Drug | Guidelines on Regulatory Reliance on the Conduct of Clinical Trials | Clinical | Visit Page |
USA | Food and Drug Administration | 4-3-23 | Medical Device | Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway | Regulatory | Visit Page |
Europe | European Medicines Agency | 3-3-23 | Drug | European Pharmacopoeia Commission creates new Excipients Strategy Working Party | Regulatory | Visit Page |
USA | Food and Drug Administration | 2-3-23 | Drug | Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens; Draft Guidance for Industry | Regulatory | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 1-3-23 | Drug | New Mobile technologies guidance document for human and veterinary medicinal products | packaging | Visit Page |
Europe | European Medicines Agency | 1-3-23 | Medical Device | Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP) | Clinical | Visit Page |
Europe | European Medicines Agency | 1-3-23 | Medical Device | Extension of the MDR transitional period and removal of the ‘sell off’ periods | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-3-23 | Drug | Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics (draft guidance) | Clinical | Visit Page |
USA | Food and Drug Administration | 1-3-23 | Drug | Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-3-23 | Drug | Development of Local Anesthetic Drug Products with Prolonged Duration of Effect | Clinical | Visit Page |
USA | Food and Drug Administration | 1-3-23 | Medical Device | Total Product Life Cycle Advisory Program (TAP) | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-3-23 | Drug | Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments | Regulatory | Visit Page |
Malaysia | Medical Device Authority | 28-2-23 | Medical Device | Notification of custom-made medical device | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-2-23 | Drug | CDER Continues to Advance Rare Disease Drug Development with New Efforts, Including the Accelerating Rare Disease Cures (ARC) Program | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 27-2-23 | Drug | Windsor Framework unveiled to fix problems of the Northern Ireland Protocol | Regulatory | Visit Page |
New Zealand | New Zealand Medicines and Medical Devices Safety | 27-2-23 | Drug | Outcome of the consultation on the proposed warning and advisory statements for ocular decongestants for eye redness and/or minor eye irritation | Safety | Visit Page |
Malaysia | Medical Device Authority | 24-2-23 | Medical Device | Malaysia MDA introduces new online payment system | Regulatory | Visit Page |
USA | Food and Drug Administration | 23-2-23 | Medical Device | Examples of Medical Device Misconnections | Regulatory | Visit Page |
Europe | European Medicines Agency | 22-2-23 | Drug | Question and Answer on the submission of applications for the expert panels’ advice to manufacturers | Regulatory | Visit Page |
USA | Food and Drug Administration | 21-2-23 | Drug | Press Statement: 21 February 2023 FDA Philippines Launches Task Force Fleming to Make Safe and Effective Covid-19 Drugs More Accessible to All Filipinos | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 20-2-23 | Medical Device | Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU | Regulatory | Visit Page |
Europe | European Medicines Agency | 16-2-23 | Biologics | Adjuvants in vaccines for human use - Scientific guideline | Regulatory | Visit Page |
Europe | European Medicines Agency | 10-2-23 | Drug | Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9 February 2023 | Pharmacovigilance | Visit Page |
Europe | European Medicines Agency | 9-2-23 | Drug | Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR) | Clinical | Visit Page |
USA | Food and Drug Administration | 9-2-23 | Medical Device | Medical Device Material Safety Summaries | Safety | Visit Page |
Australia | Therapeutic Goods Administration | 8-2-23 | Drug | Avoid prescribing pregabalin in pregnancy if possible | Safety | Visit Page |
USA | Food and Drug Administration | 8-2-23 | Drug | Artificial Intelligence/Machine Learning Assisted Image Analysis for Characterizing Biotherapeutics | Regulatory | Visit Page |
USA | Food and Drug Administration | 7-2-23 | Drug | ANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements | Regulatory | Visit Page |
Global | International Medical Device Regulators Forum | 7-2-23 | Medical Device | IMDRF Terms of Reference | Regulatory | Visit Page |
Europe | European Medicines Agency | 6-2-23 | Drug | Guidance for Stepwise PIP pilot | Clinical | Visit Page |
Europe | European Medicines Agency | 6-2-23 | Drug | EFPIA response to EU Commission proposal for revised EMA Fees regulation | Regulatory | Visit Page |
Global | International Medical Device Regulators Forum | 3-2-23 | Medical Device | Medical Device Regulatory Review Report: Guidance Regarding Information to be Included | Regulatory | Visit Page |
Europe | European Medicines Agency | 3-2-23 | Drug | Public consultation on a multi-stakeholder platform to improve clinical trials in the EU | Clinical | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 3-2-23 | Medical Device | Medical technology strategy | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 3-2-23 | Drug | Change to classification of psilocybin and MDMA to enable prescribing by authorized psychiatrists. | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 3-2-23 | Drug | TGA makes interim decision to reduce maximum paracetamol pack sizes. | Regulatory | Visit Page |
Europe | European Medicines Agency | 3-2-23 | Drug | ICH guideline Q9 (R1) on quality risk management | Quality | Visit Page |
USA | Food and Drug Administration | 3-2-23 | Medical Device | Total Product Life Cycle Advisory Program (TAP) | Regulatory | Visit Page |
Europe | European Union | 1-2-23 | Medical Device | Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices | Regulatory | Visit Page |
Europe | European Union | 1-2-23 | Medical Device | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-2-23 | Drug | Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-2-23 | Drug | Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment (draft guidance) | Clinical | Visit Page |
The Philippines | Philippines FDA | 1-2-23 | Drug | Guidelines on Food and Drug Administration’s Regulatory Responses During Declared National or State of Public Health Emergencies (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-2-23 | Drug | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development (draft guidance) | Clinical | Visit Page |
USA | Food and Drug Administration | 1-2-23 | Drug | Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment (draft guidance) | Clinical | Visit Page |
USA | Food and Drug Administration | 1-2-23 | Drug | Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (draft guidance) | Regulatory | Visit Page |
Europe | European Medicines Agency | 31-1-23 | Drug | Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU | Clinical | Visit Page |
USA | Food and Drug Administration | 31-1-23 | Medical Device | Surveying, Leveling, and Alignment Laser Products | Regulatory | Visit Page |
Ireland | Health Products Regulatory Authority | 30-1-23 | Drug | Fees for Human Products | Regulatory | Visit Page |
USA | Food and Drug Administration | 27-1-23 | Medical Device | Health Canada and FDA eSTAR Pilot | Regulatory | Visit Page |
Europe | European Medicines Agency | 26-1-23 | Drug | ICH Guideline M13A on bioequivalence for immediate release solid oral dosage forms | Clinical | Visit Page |
Mexico | COFEPRIS | 25-1-23 | Drug | Mexico proposes a Latin American Medicines Agency for health self-sufficiency | Regulatory | Visit Page |
Europe | European Union | 25-1-23 | Medical Device | Scientific advice pilot for high-risk medical devices device | Regulatory | Visit Page |
USA | Food and Drug Administration | 24-1-23 | Drug | Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Guidance for Industry; Availability | Clinical | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 24-1-23 | Drug | European Commission Decision Reliance Procedure (ECDRP) extension | Regulatory | Visit Page |
Europe | European Medicines Agency | 23-1-23 | Drug | Pharmacovigilance Risk Assessment Committee (PRAC): Work Plan 2023 | Pharmacovigilance | Visit Page |
USA | Food and Drug Administration | 20-1-23 | Medical Device | Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products | Regulatory | Visit Page |
Europe | European Medicines Agency | 20-1-23 | Drug | Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines | Regulatory | Visit Page |
USA | Food and Drug Administration | 20-1-23 | Medical Device | Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions | Regulatory | Visit Page |
USA | Food and Drug Administration | 20-1-23 | Medical Device | Ophthalmic Devices; Classification of the Intense Pulsed Light Device for Managing Dry Eye | Regulatory | Visit Page |
USA | Food and Drug Administration | 20-1-23 | Medical Device | Radiological Health Regulations: Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products | Regulatory | Visit Page |
Europe | European Medicines Agency | 19-1-23 | Drug | Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications | Clinical | Visit Page |
USA | Food and Drug Administration | 17-1-23 | Medical Device | Classification of the Prognostic Test for Assessment of Liver Related Disease Progression | Regulatory | Visit Page |
USA | Food and Drug Administration | 13-1-23 | Medical Device | Classification of the Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions | Regulatory | Visit Page |
Malaysia | Medical Device Authority | 13-1-23 | Medical Device | Requirements for application of Certificate Of Free Sale (CFS), Manufacturing Certificate (MC) and Certificate Of Free Sale For Export only (CFS EO) medical devices (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 12-1-23 | Medical Device | Photobiomodulation (PBM) Devices - 2 Premarket Notification [510(k)] 3 Submissions (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 12-1-23 | Medical Device | Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice | Regulatory | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 11-1-23 | Drug | Position paper by Swissmedic and swissethics on decentralized clinical trials (DCTs) with medicinal products | Clinical | Visit Page |
Europe | European Union | 6-1-23 | Medical Device | Questions and Answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation | Regulatory | Visit Page |
Europe | European Union | 6-1-23 | Medical Device | More time to certify medical devices under MDR to mitigate risks of shortages | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-1-23 | Medical Device | Orthopedic Devices; Classification of the Bone Indentation Device | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-1-23 | Medical Device | Orthopedic Devices; Classification of the Implantable Post-Surgical Kinematic Measurement Knee Device | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-1-23 | Medical Device | Neurological Devices; Classification of the Brain Stimulation Programming Planning Software | Regulatory | Visit Page |
New Zealand | New Zealand Medicines and Medical Devices Safety | 3-1-23 | Drug-Device Combination | Guideline on the Regulation of Therapeutic Products in New Zealand | Regulatory | Visit Page |
The Philippines | Philippines FDA | 3-1-23 | Drug | Updated Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices (draft for comments) | Regulatory | Visit Page |
The Philippines | Philippines FDA | 3-1-23 | Medical Device | Guidelines on the Conduct of Regulatory Inspections for Radiation Facilities | Regulatory | Visit Page |
Europe | European Medicines Agency | 3-1-23 | Drug | Coordination of pharmacovigilance inspections | Pharmacovigilance | Visit Page |
Europe | European Union | 3-1-23 | Medical Device | List of standard fees | Regulatory | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 3-1-23 | Medical Device | MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured | Regulatory | Visit Page |
Malaysia | National Pharmaceutical Regulatory Agency | 3-1-23 | Drug-Device Combination | Guideline for drug-medical device and medical device-drug combination products - endorsement letter application - adverse drug reaction and incident reporting | Regulatory | Visit Page |
Europe | European Medicines Agency | 3-1-23 | Drug | Pharmeuropa 35.1 just released | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-1-23 | Medical Device | Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-1-23 | Drug | Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (draft guidance) | Clinical | Visit Page |
Malaysia | Medical Device Authority | 1-1-23 | Medical Device | How to submit an application for registration of a refurbished medical device | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-1-23 | Drug | Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (draft guidance) | Labeling | Visit Page |
Europe | European Medicines Agency | 1-1-23 | Drug | Guidance on good manufacturing practice and good distribution practice: Questions and answers | Regulatory | Visit Page |
Europe | European Union | 1-1-23 | Medical Device | Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | Regulatory | Visit Page |
Netherlands | Medicines Evaluation Board | 1-1-23 | Drug | Changes to fees for human medicinal products and devices as of 1 January 2023 | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-1-23 | Format and Content of a REMS Document | Format and Content of a REMS Document | Safety | Visit Page |
USA | Food and Drug Administration | 30-12-22 | Medical Device | Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-12-22 | Medical Device | Classification of the Interventional Cardiovascular Implant Simulation Software Device | Regulatory | Visit Page |
USA | Food and Drug Administration | 27-12-22 | Medical Device | Classification of the Adjunctive Hemodynamic Indicator with Decision Point | Regulatory | Visit Page |
USA | Food and Drug Administration | 23-12-22 | Drug | FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs | Regulatory | Visit Page |
USA | Food and Drug Administration | 22-12-22 | Drug | Controlled Correspondence Related to Generic Drug Development (draft guidance) | Regulatory | Visit Page |
International | The International Council for Harmonisation | 20-12-22 | Drug | Bioequivalence for immediate release solid oral dosage forms M13A | Regulatory | Visit Page |
USA | Food and Drug Administration | 20-12-22 | Medical Device | Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices | Safety | Visit Page |
Global | International Medical Device Regulators Forum | 19-12-22 | Medical Device | IMDRF Standard Operating Procedures | Regulatory | Visit Page |
Europe | European Medicines Agency | 16-12-22 | Drug | EMA Management Board: highlights of December 2022 meeting | Regulatory | Visit Page |
Europe | European Union | 16-12-22 | Medical Device | Guidance on Periodic Safety Update Report (PSUR) according to regulation (EU) 2017/745 (MDR) | Safety | Visit Page |
USA | Food and Drug Administration | 15-12-22 | Drug | Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 15-12-22 | Drug | Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (draft guidance) | Regulatory | Visit Page |
Singapore | Health Sciences Authority | 14-12-22 | Drug | Mean applicant screening response time | Regulatory | Visit Page |
USA | Food and Drug Administration | 14-12-22 | Drug | FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal | Labeling | Visit Page |
USA | Food and Drug Administration | 14-12-22 | Drug | Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe | Regulatory | Visit Page |
Europe | European Union | 14-12-22 | Medical Device | Substantial modification of performance study under Regulation (EU) 2017/746 | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 13-12-22 | Drug | Inspections/Audits of Pharmacovigilance (PV) system of importers and manufacturers of human vaccine | Pharmacovigilance | Visit Page |
Europe | European Union | 13-12-22 | Drug | Commission proposes updated EMA fees | Regulatory | Visit Page |
USA | Food and Drug Administration | 9-12-22 | Drug | Pulmonary Tuberculosis: Developing Drugs for Treatment (draft guidance) | Clinical | Visit Page |
Australia | Therapeutic Goods Administration | 9-12-22 | Drug | Safety advisory - Low levels of contamination with N-nitroso-quinapril | Safety | Visit Page |
USA | Food and Drug Administration | 9-12-22 | Medical Device | Content of Human Factors Information in Medical Device Marketing Submissions (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 9-12-22 | Drug | CMC Reviews of Type III DMFs for Packaging Materials | Packaging | Visit Page |
USA | Food and Drug Administration | 9-12-22 | Drug | Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria | Regulatory | Visit Page |
USA | Food and Drug Administration | 9-12-22 | Medical Device | Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 8-12-22 | Drug | Acceptability of Standards from Alternative Compendia (BP/EP/JP) | Regulatory | Visit Page |
Europe | European Union | 8-12-22 | Medical Device | MDCG position paper on ‘hybrid audits’ | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 7-12-22 | Drug | Changes to pharmaceutical database based on feedback received | Regulatory | Visit Page |
USA | Food and Drug Administration | 7-12-22 | Medical Device | Augmented Reality and Virtual Reality in Medical Devices | Regulatory | Visit Page |
USA | Food and Drug Administration | 7-12-22 | Drug | Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) | Regulatory | Visit Page |
Europe | European Union | 6-12-22 | Medical Device | Proposal to delay the implementation of the Medical Device Regulation | Regulatory | Visit Page |
USA | Food and Drug Administration | 6-12-22 | Drug | Homeopathic Drug Products | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-12-22 | Drug | E19 A selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials | Clinical | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 5-12-22 | Medical Device | Guidance for manufacturers on vigilance | Pharmacovigilance | Visit Page |
USA | Food and Drug Administration | 5-12-22 | Drug | Statistical Approaches to Establishing Bioequivalence (draft guidance) | Regulatory | Visit Page |
Europe | European Union | 2-12-22 | Medical Device | Regulations to lay down common specifications and rules for reclassification of products without an intended medical purpose under the Medical Devices Regulation (MDR) | Regulatory | Visit Page |
Europe | European Medicines Agency | 2-12-22 | Drug | EMA recommends withdrawal of pholcodine medicines from EU market | Regulatory | Visit Page |
USA | Food and Drug Administration | 2-12-22 | Drug | ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions (draft guidance) | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 30-11-22 | Drug | A warning that advertising Ozempic (semaglutide) is prohibited | Labeling | Visit Page |
Ireland | Health Products Regulatory Authority | 28-11-22 | Drug | Update on review of over-the-counter medicines containing codeine. | Regulatory | Visit Page |
Malaysia | Medical Device Authority | 21-11-22 | Medical Device | Change notification for registered medical device | Regulatory | Visit Page |
Malaysia | Medical Device Authority | 21-11-22 | Medical Device | Requirements for labelling of medical devices | Labeling | Visit Page |
USA | Food and Drug Administration | 17-11-22 | Drug | Upcoming Product-Specific Guidances for Generic Drug Product Development | Regulatory | Visit Page |
Global | INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE | 16-11-22 | Drug | Continuous manufacturing of drug substances and drug products Q13 | Regulatory | Visit Page |
USA | Food and Drug Administration | 15-11-22 | Drug | FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 15-11-22 | Medical Device | Post-market review of ventilators, CPAP and BiPAP devices | Pharmacovigilance | Visit Page |
USA | Food and Drug Administration | 14-11-22 | Medical Device | Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents | Regulatory | Visit Page |
Europe | European Medicines Agency | 10-11-22 | Biologics | Reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances | Regulatory | Visit Page |
Indonesia | BADAN POM | 9-11-22 | Drug | Explanation of BPOM RI number HM.01.1.2.11.22.178 dated 9 November 2022 regarding development of results of supervision of drug syrup and procedure of propylene glycol raw materials containing contaminants EG and DEG exceed the limits | Regulatory | Visit Page |
Malaysia | Medical Device Authority | 9-11-22 | Medical Device | Notification of custom-made medical device - Guidance document | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 8-11-22 | Drug | Submission of Suspected Unexpected Serious Adverse Reactions reports using ICSR submissions or MHRA gateway | Safety | Visit Page |
Australia | Therapeutic Goods Administration | 7-11-22 | Drug | International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names | Labeling | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 7-11-22 | Biologics | Guidance on the licensing of biosimilar products | Regulatory | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 4-11-22 | Drug | Changes to the Guidance document Variations TAM HMV4 | Regulatory | Visit Page |
Europe | European Medicines Agency | 3-11-22 | Drug | Regulatory update - EMA encourages companies to submit type I variations for 2022 by end of November | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 3-11-22 | Medical Device | Post-market review of spinal cord stimulation (SCS) devices | Pharmacovigilance | Visit Page |
The Philippines | Philippines FDA | 1-11-22 | Drug | Guidelines Prescribing the Principle of Reliance for Regulatory Decisions of the Food and Drug Administration | Regulatory | Visit Page |
The Philippines | Philippines FDA | 1-11-22 | Drug | Guidelines on Food and Drug Administration’s Regulatory Responses During Declared National Public Health Emergencies | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-11-22 | Drug | Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-11-22 | Drug | Sameness Evaluations in an ANDA — Active Ingredients (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-11-22 | Biologics | Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-11-22 | Drug | M10 Bioanalytical method validation and study sample analysis | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-11-22 | Drug | Cross Labeling Oncology Drugs in Combination Regimens | Labeling | Visit Page |
USA | Food and Drug Administration | 1-11-22 | Drug | S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals | Non-Clinical | Visit Page |
USA | Food and Drug Administration | 1-11-22 | Biologics | Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial | Clinical | Visit Page |
USA | Food and Drug Administration | 1-11-22 | Drug | Expanded Access to Investigational Drugs for Treatment Use Questions and Answers (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 31-10-22 | Drug | Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement | CMC | Visit Page |
Europe | European Union | 28-10-22 | Drug | The Council of Europe/EDQM and the European Union conclude an agreement expanding the scope of their co-operation in the field of substances of human origin | Regulatory | Visit Page |
China | National Medical Products Administration | 27-10-22 | Drug | NMPA Announcement on putting into use the electronic certificates of Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 27-10-22 | Drug | IPC's Notice Regarding General Chapters of IP 2022 | Regulatory | Visit Page |
USA | Food and Drug Administration | 27-10-22 | Drug | Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials (draft guidance) | Clinical | Visit Page |
USA | Food and Drug Administration | 26-10-22 | Drug | Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 25-10-22 | Medical Device | Implementation of the Future Regulations | Regulatory | Visit Page |
USA | Food and Drug Administration | 25-10-22 | Drug | In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 25-10-22 | Drug | Human Gene Therapy for Neurodegenerative Diseases | Clinical | Visit Page |
Europe | European Medicines Agency | 24-10-22 | Drug | Information about the raw data proof-of-concept pilot for industry | Clinical | Visit Page |
USA | Food and Drug Administration | 21-10-22 | Drug | In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 21-10-22 | Drug | Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 21-10-22 | Drug | Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (draft guidance) | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 21-10-22 | Drug | GMP Clearance: Temporary changes to target processing times | Regulatory | Visit Page |
USA | Food and Drug Administration | 21-10-22 | Medical Device | Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 20-10-22 | Drug | Multiple Endpoints in Clinical Trials | Clinical | Visit Page |
USA | Food and Drug Administration | 19-10-22 | Drug | Advancing Real-World Evidence Program | Regulatory | Visit Page |
Europe | European Medicines Agency | 18-10-22 | Drug | Anonymization of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs (main body and annexes 4 and 6) | Pharmacovigilance | Visit Page |
USA | Food and Drug Administration | 18-10-22 | Drug | ANDA Submissions – Prior Approval Supplements Under GDUFA | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 17-10-22 | Medical Device | Software and AI as a Medical Device Change Programme - Roadmap | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 17-10-22 | Drug | Pharmacovigilance Inspection Program Risk Assessment Survey | Pharmacovigilance | Visit Page |
USA | Food and Drug Administration | 17-10-22 | Drug | Tissue Agnostic Drug Development in Oncology | Clinical | Visit Page |
USA | Food and Drug Administration | 17-10-22 | Drug | Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials | Clinical | Visit Page |
USA | Food and Drug Administration | 17-10-22 | Drug | Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment | Clinical | Visit Page |
USA | Food and Drug Administration | 17-10-22 | Drug | Complex Generics News | Regulatory | Visit Page |
Europe | European Medicines Agency | 14-10-22 | Drug | European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance | Clinical | Visit Page |
USA | Food and Drug Administration | 14-10-22 | Drug | Comparability Protocols for Post approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA | CMC | Visit Page |
USA | Food and Drug Administration | 12-10-22 | Drug | Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 11-10-22 | Medical Device | Classification of medical device pertaining to oncology under the provisions of medical devices rules, 2017 | Regulatory | Visit Page |
Denmark | Danish Medicines Agency | 11-10-22 | Drug | Current Danish QRD template to be used in connection with the granting of marketing authorizations | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 7-10-22 | Drug | GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 7-10-22 | Drug | Boundary and combination products guidance - medicines, medical devices, and biologicals | Regulatory | Visit Page |
USA | Food and Drug Administration | 7-10-22 | Medical Device | Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order | Clinical | Visit Page |
USA | Food and Drug Administration | 6-10-22 | Medical Device | Post market Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-10-22 | Drug | Prioritization of the Review of Original ANDAs, Amendments, and Supplements | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-10-22 | Drug | Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-10-22 | Drug | Information Requests and Discipline Review Letters Under GDUFA | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-10-22 | Drug | Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA | Regulatory | Visit Page |
USA | Food and Drug Administration | 5-10-22 | Drug | Competitive Generic Therapies | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Drug | Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (draft guidance) | Regulatory | Visit Page |
Europe | European Union | 3-10-22 | Medical Device | Guidance on Authorized Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Drug | Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA (Draft guidance) | CMC | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Medical Device | FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Medical Device | FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Medical Device | FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Drug | Facility Readiness: Goal Date Decisions Under GDUFA (Draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-10-22 | Drug | Split Real Time Application Review (STAR) | Regulatory | Visit Page |
The Philippines | Philippines FDA | 3-10-22 | Drug | Amendment to Administrative Order No. 2020-0017 entitled, “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003” (Draft guidance) | Regulatory | Visit Page |
Ireland | Health Products Regulatory Authority | 1-10-22 | Drug | Public Consultation on Annual Review and Proposal for Fees – Financial Year 2023 | Regulatory | Visit Page |
Europe | European Medicines Agency | 30-9-22 | Drug | Data Quality Framework for EU medicines regulation | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 30-9-22 | Drug | European Commission Decision Reliance Procedure (EC DRP) extension | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 30-9-22 | Medical Device | Regulation of all Class A & B Medical Devices under Licensing regime | Regulatory | Visit Page |
Global | INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE | 29-9-22 | Drug | Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin Q5A(R2) | Safety | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 29-9-22 | Medical Device | MHRA appoints first new UK Approved Body to certify medical devices since Brexit | Regulatory | Visit Page |
Europe | European Medicines Agency | 29-9-22 | Drug | EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 28-9-22 | Drug | User experience survey - Database of Adverse Event Notifications (DAEN) – medicines beta version | Safety | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Medical Device | Display Devices for Diagnostic Radiology | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Medical Device | Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Medical Device | Clinical Decision Support Software | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Medical Device | Policy for Device Software Functions and Mobile Medical Applications | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Drug | Protection of Human Subjects and Institutional Review Boards | Regulatory | Visit Page |
USA | Food and Drug Administration | 28-9-22 | Vaccine | Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised); Immediately in Effect Guidance for Commercial Manufacturers and Food and Drug Administration Staff; Availability | Regulatory | Visit Page |
Global | INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE | 27-9-22 | Drug | Clinical electronic structured harmonized protocol (CESHARP) M11 | Clinical | Visit Page |
Global | INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE | 27-9-22 | Drug | A selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials E19 | Safety | Visit Page |
The Philippines | Philippines FDA | 27-9-22 | Medical Device | Abridged Processing of Application for Registration of Medical Devices Approved by the National Regulatory Authority of Any ASEAN Member Country | Regulatory | Visit Page |
USA | Food and Drug Administration | 23-9-22 | Drug | New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials | Clinical | Visit Page |
USA | Food and Drug Administration | 22-9-22 | Medical Device | Electronic Submission Template for Medical Device 510(k) Submissions | Regulatory | Visit Page |
Europe | European Medicines Agency | 19-9-22 | Biologics | Policy for Monkeypox Tests to Address the Public Health Emergency, Guidance for Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff | Regulatory | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 14-9-22 | Drug | Potential nitrosamine contamination – harmonised implementation (update) | Regulatory | Visit Page |
Japan | Pharmaceuticals and Medical Devices Agency | 13-9-22 | Drug | Labeling of Codes on Containers to Identify Regenerative Medical Products, etc | Labeling | Visit Page |
Japan | Pharmaceuticals and Medical Devices Agency | 13-9-22 | Drug | Labeling of Codes on Containers to Identify Prescription Drugs | Labeling | Visit Page |
Europe | European Commission | 8-9-22 | Medical Device | Medical devices - reclassification of products without an intended medical purpose | Regulatory | Visit Page |
Europe | European Medicines Agency | 2-9-22 | Drug | Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022 | Pharmacovigilance | Visit Page |
Europe | European Medicines Agency | 1-9-22 | Drug | Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-9-22 | Drug | Providing Over-the-Counter Monograph Submissions in Electronic Format (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-9-22 | Drug | Ethical Considerations for Clinical Investigations of Medical Products Involving Children | Clinical | Visit Page |
USA | Food and Drug Administration | 1-9-22 | Drug | General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products Guidance for Industry | Pharmacovigilance | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 1-9-22 | Drug | Canada - United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 31-8-22 | Drug | Consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees | Regulatory | Visit Page |
Malaysia | Medical Device Authority | 30-8-22 | Medical Device | Licensing for establishment | Regulatory | Visit Page |
The Philippines | Philippines FDA | 23-8-22 | Drug | Guidelines on Regulatory Reliance on the Conduct of Clinical Trials in the Philippines (draft for comments) | Clinical | Visit Page |
Australia | Therapeutic Goods Administration | 17-8-22 | Medical Device | Exemption for Certain Clinical Decision Support Software | Clinical | Visit Page |
USA | Food and Drug Administration | 17-8-22 | Medical Device | Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices | Regulatory | Visit Page |
USA | Food and Drug Administration | 17-8-22 | Medical Device | Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions (draft guidance) | Labeling | Visit Page |
USA | Food and Drug Administration | 17-8-22 | Medical Device | Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 17-8-22 | Medical Device | Regulation of software based medical devices | Regulatory | Visit Page |
Singapore | Health Sciences Authority | 12-8-22 | Medical Device | Potential increase of mortality and amputation risk associated with paclitaxel-coated devices | Safety | Visit Page |
Europe | European Commission | 10-8-22 | Medical Device | MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies | Regulatory | Visit Page |
USA | Food and Drug Administration | 10-8-22 | Medical Device | Ethylene Oxide Risk from Commercial Sterilizers | Regulatory | Visit Page |
International | The International Council for Harmonisation | 4-8-22 | Drug | Testing for carcinogenicity of pharmaceuticals | Safety | Visit Page |
Europe | European Directorate for the Quality of Medicines and Healthcare | 4-8-22 | Drug | itrosamines – Deadline extension for all CEP holders to complete step 3 Revision to the CEP (now 1 October 2023) | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 4-8-22 | Medical Device | Classification of medical devices pertaining to rehabilitation under the provisions of Medical Devices rule | Regulatory | Visit Page |
USA | Food and Drug Administration | 3-8-22 | Medical Device | Sterilization for Medical Devices | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 1-8-22 | Drug | Regulatory options to potentially allow references to the TGA in therapeutic goods advertising | Labeling | Visit Page |
Malaysia | Medical Device Authority | 1-8-22 | Medical Device | Harmonized classification of medical devices in ASEAN | Regulatory | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 1-8-22 | Drug | Changes to Guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4 | Regulatory | Visit Page |
Europe | European Medicines Agency | 1-8-22 | Drug | Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-8-22 | Drug | Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies (draft guidance) | Publishing | Visit Page |
India | Central Drugs Standard Control Organisation | 29-7-22 | Medical Device | Price control on medical devices | Regulatory | Visit Page |
Europe | European Medicines Agency | 28-7-22 | Drug | Key performance indicators (KPIs) to monitor the European clinical trials environment | Clinical | Visit Page |
Europe | European Medicines Agency | 28-7-22 | Drug | Big Data Workplan 2022-2025 | Regulatory | Visit Page |
New Zealand | New Zealand Medicines and Medical Devices Safety | 27-7-22 | Drug | Outcome of the consultation on the proposed warning and advisory statements relating to the harm of opioid abuse | Labeling | Visit Page |
Europe | European Medicines Agency | 27-7-22 | Drug | EMA response to the monkeypox public health emergency | Regulatory | Visit Page |
USA | Food and Drug Administration | 25-7-22 | Medical Device | Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices | Regulatory | Visit Page |
USA | Food and Drug Administration | 25-7-22 | Drug | Proposed Rule on Revising the National Drug Code Format | Labeling | Visit Page |
USA | Food and Drug Administration | 22-7-22 | Drug | FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health | Regulatory | Visit Page |
Europe | European Medicines Agency | 21-7-22 | Drug | ICH Guideline M12 on drug interaction studies (draft guidance) | Clinical | Visit Page |
Australia | Therapeutic Goods Administration | 20-7-22 | Drug | Nitrosamine impurities in medicines - Information for sponsors and manufacturers | Regulatory | Visit Page |
USA | Food and Drug Administration | 18-7-22 | Medical Device | Tracking Your Premarket Submission’s Progress (Progress Tracker) | Regulatory | Visit Page |
Europe | European Medicines Agency | 15-7-22 | Drug | Towards better prevention of medicine shortages in the EU | Regulatory | Visit Page |
Europe | European Commission | 14-7-22 | Biologics | Questions and answers on the proposal for a new legislation on blood, tissues, and cells | Regulatory | Visit Page |
Europe | European Commission | 13-7-22 | Medical Device | MDCG 2022-12 - Harmonized administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR) | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 12-7-22 | Drug | Import, Advertising and Supply Compliance Priorities 2022-23 | Regulatory | Visit Page |
Europe | European Medicines Agency | 12-7-22 | Drug | Information about the raw data proof-of-concept pilot for industry | Clinical | Visit Page |
Europe | European Medicines Agency | 11-7-22 | Drug | Concept paper on the revision of the guideline on the chemistry of active substances | Regulatory | Visit Page |
New Zealand | New Zealand Medicines and Medical Devices Safety | 11-7-22 | Drug | Proposed warning and advisory statement for ocular decongestants used for eye redness and/or minor eye irritation: Do not use in children under 12 years of age | Safety | Visit Page |
Europe | European Medicines Agency | 11-7-22 | Vaccine | ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 11-7-22 | Medical Device | Clarification on medical devices quality certificates | Regulatory | Visit Page |
Europe | European Medicines Agency | 8-7-22 | Drug | Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimize risk of meningioma | Pharmacovigilance | Visit Page |
Europe | European Medicines Agency | 8-7-22 | Drug | List of the “main therapeutic groups” (MTGs) in crisis preparedness | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 7-7-22 | Medical Device | Guidance on Stability Studies of In-vitro Diagnostic Medical Device (draft guidance) | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 7-7-22 | Medical Device | Guidance on post-market surveillance of In-Vitro Diagnostic Medical Device (draft guidance) | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 7-7-22 | Medical Device | Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) (draft guidance) | Regulatory | Visit Page |
Australia | Therapeutic Goods Administration | 4-7-22 | Biologics | Report on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives' - TGA response | Regulatory | Visit Page |
Europe | European Commission | 4-7-22 | Medical Device | Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council | Regulatory | Visit Page |
Malaysia | National Pharmaceutical Regulatory Agency | 1-7-22 | Drug | Active Pharmaceutical Ingredient (API) Information (PART II S) for product registration application via quest system | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug | Changes to Disposable Manufacturing Materials: Questions and Answers | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug | Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings | Clinical | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug and Biological Product | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products | Clinical | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug and Biological Product | Real-Time Oncology Review (RTOR) (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug | Orange Book Questions and Answers | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug | Conducting Remote Regulatory Assessments Questions and Answers (draft guidance) | Regulatory | Visit Page |
Europe | European Commission | 1-7-22 | Medical Device | First Spanish group designated under MDR | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug | Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding” (draft guidance) | Labeling | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug | Evaluation of Therapeutic Equivalence (draft guidance) | Regulatory | Visit Page |
The Philippines | Philippines FDA | 1-7-22 | Medical Device | Amendment to FDA Circular NO. 2017-013, entitled, “guidelines on the issuance of clearance for customs release (CFCR) of radiation devices | Regulatory | Visit Page |
Malaysia | National Pharmaceutical Regulatory Agency | 1-7-22 | Drug | Malaysian variation guideline for pharmaceutical products | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug | Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format | Labeling | Visit Page |
Europe | European Medicines Agency | 1-7-22 | Drug | Quality of medicines questions and answers: Part 2 | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug | Identifying Trading Partners Under the Drug Supply Chain Security Act (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-7-22 | Drug | DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 30-6-22 | Medical Device | General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma | Regulatory | Visit Page |
Europe | European Medicines Agency | 28-6-22 | Drug | Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability | Regulatory | Visit Page |
UK | Medicines and Healthcare products Regulatory Agency | 27-6-22 | Medical Device | UK to strengthen regulation of medical devices to protect patients | Regulatory | Visit Page |
USA | Food and Drug Administration | 27-6-22 | Drug | Nonprescription Drug Product with an Additional Condition for Nonprescription Use | Regulatory | Visit Page |
New Zealand | New Zealand Medicines and Medical Devices Safety | 27-6-22 | Drug | Outcome of the consultation on the proposed warning and advisory statements relating to harm of long-term use and overuse of stimulant laxatives | Labeling | Visit Page |
Australia | Therapeutic Goods Administration | 27-6-22 | Medical Device | Clinical evidence guidelines for medical devices | Clinical | Visit Page |
USA | Food and Drug Administration | 24-6-22 | Drug | Considerations for the Development of Oligonucleotide Therapeutics (draft guidance) | Clinical | Visit Page |
Malaysia | Medical Device Authority | 24-6-22 | Medical Device | Medical device guidance document licensing for establishment | Regulatory | Visit Page |
The Philippines | Philippines FDA | 23-6-22 | Drug | Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price (MRP) | Labeling | Visit Page |
USA | Food and Drug Administration | 23-6-22 | Drug | Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 23-6-22 | Drug | Assessing the Effects of Food on Drugs in Investigational New Drugs and New Drug Applications—Clinical Pharmacology Considerations | Clinical | Visit Page |
USA | Food and Drug Administration | 23-6-22 | Drug and Biological Product | Considerations for Rescinding Breakthrough Therapy Designation | Regulatory | Visit Page |
USA | Food and Drug Administration | 21-6-22 | Medical Device | Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures | Clinical | Visit Page |
Europe | European Commission | 20-6-22 | Medical Device | Tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices | Regulatory | Visit Page |
Europe | European Commission | 20-6-22 | Medical Device | Fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices | Regulatory | Visit Page |
Europe | European Medicines Agency | 17-6-22 | Medical Device | Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics | Regulatory | Visit Page |
The Philippines | Philippines FDA | 16-6-22 | Drug and Biological Product | Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 “Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals | Regulatory | Visit Page |
USA | Food and Drug Administration | 16-6-22 | Biologics | Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 16-6-22 | Medical Device | Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions | Regulatory | Visit Page |
Ireland | Health Products Regulatory Authority | 15-6-22 | Medical Device | Guide to Performance Studies Conducted in Ireland | Clinical | Visit Page |
USA | Food and Drug Administration | 15-6-22 | Drug | Q9(R1) Quality Risk Management; International Council for Harmonization (draft guidance) | Quality | Visit Page |
Europe | European Medicines Agency | 15-6-22 | Vaccine | Start of rolling review for adapted Comirnaty COVID-19 vaccine | Regulatory | Visit Page |
India | Central Drugs Standard Control Organisation | 14-6-22 | Drug | Draft proposal to include bar codes or QR codes for identified medicinal products | Labeling | Visit Page |
USA | Food and Drug Administration | 14-6-22 | Drug | Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials (Draft Guidance) | Clinical | Visit Page |
Europe | European Commission | 13-6-22 | Medical Device | MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements | Regulatory | Visit Page |
The Philippines | Philippines FDA | 10-6-22 | Drug | Banning of all Mercury-Added Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes | Regulatory | Visit Page |
Malaysia | Medical Device Authority | 8-6-22 | Medical Device | Guideline for re-registration of registered medical device | Regulatory | Visit Page |
Italy | Italian Medicines Agency | 7-6-22 | Drug | Launch of new Pharmacovigilance Network | Pharmacovigilance | Visit Page |
USA | Food and Drug Administration | 7-6-22 | Medical Device | Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices--Questions and Answers (Revised); Withdrawal of Guidance | Regulatory | Visit Page |
USA | Food and Drug Administration | 6-6-22 | Drug and Biological Product | Assessment of the Appropriate Net Container Content for Injectable Drug and Biological Products | Regulatory | Visit Page |
USA | Food and Drug Administration | 6-6-22 | Medical Device | Gastroenterology-Urology Devices; Classification of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation | Regulatory | Visit Page |
Europe | European Commission | 3-6-22 | Medical Device | EFPIA statement on the concerning impact of the In Vitro Diagnostic Regulation | Clinical | Visit Page |
France | French National Agency for the Safety of Medicines and Health Products | 2-6-22 | Drug | New edition of good pharmacovigilance practices | Pharmacovigilance | Visit Page |
Europe | European Commission | 2-6-22 | Drug | Questions and answers - Complex clinical trials | Clinical | Visit Page |
Australia | Therapeutic Goods Administration | 1-6-22 | Medical Device | Uniform Recall Procedure for Therapeutic Goods (URPTG) | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-6-22 | Drug and Biological Product | Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment | Clinical | Visit Page |
USA | Food and Drug Administration | 1-6-22 | Drug and Biological Product | Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment | Clinical | Visit Page |
Japan | Pharmaceuticals and Medical Devices Agency | 1-6-22 | Drug-Device Combination | Pharmaceuticals and Medical Devices Safety Information | Safety | Visit Page |
The Philippines | Philippines FDA | 1-6-22 | Drug | Implementing Guidelines on the Collaborative Procedure for the Accelerated Registration of World Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines | Regulatory | Visit Page |
USA | Food and Drug Administration | 1-6-22 | Medical Device | Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals | Regulatory | Visit Page |
Europe | European Commission | 1-6-22 | Medical Device | Draft standardization request amending Implementing Decision C (2021) 2406 of 14.4.2021 | Regulatory | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 1-6-22 | Drug | Applications for clinical trials for medicinal products | Clinical | Visit Page |
Ireland | Health Products Regulatory Authority | 30-5-22 | Drug | Stakeholder Consultation on Registration of Processes exempted under Article 61(5) and applicable requirements under Article 61(6) of the CTR | Clinical | Visit Page |
Australia | Therapeutic Goods Administration | 27-5-22 | Medical Device | Seasonal Influenza Rapid Antigen Self-tests and Combination tests Clinical performance requirements and risk mitigation strategies | Clinical | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 26-5-22 | Medical Device | Performance studies with IVD | Clinical | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 26-5-22 | Medical Device | New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022 | Clinical | Visit Page |
Japan | Pharmaceuticals and Medical Devices Agency | 25-5-22 | Medical Device | Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products | Regulatory | Visit Page |
USA | Food and Drug Administration | 20-5-22 | Drug | Product-Specific Guidance’s; Draft and Revised Draft Guidance’s for Industry; Availability | Regulatory | Visit Page |
Europe | European Medicines Agency | 19-5-22 | Drug | Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address pediatric-specific clinical data requirements | Clinical | Visit Page |
Europe | European Medicines Agency | 19-5-22 | Drug | Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections | Clinical | Visit Page |
India | Central Drugs Standard Control Organisation | 18-5-22 | Medical Device | Suspension and cancellation of medical device licenses | Regulatory | Visit Page |
Europe | European Directorate for the Quality of Medicines and Healthcare | 18-5-22 | Drug | Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodies | Regulatory | Visit Page |
International | Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) | 16-5-22 | Drug | PIC/S work plan for 2022 | Regulatory | Visit Page |
Europe | European Commission | 11-5-22 | Medical Device | Amending Implementing Decision (EU) 2021/1182 as regards harmonized standards for quality management systems, sterilization, and application of risk management to medical devices | Quality | Visit Page |
Europe | European Medicines Agency | 11-5-22 | Drug | Public Consultation Concerning the Physical Attendance and The Location of Personal Residency of The Qualified Person | Pharmacovigilance | Visit Page |
Europe | European Medicines Agency | 10-5-22 | Drug | Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes | Clinical | Visit Page |
Australia | Therapeutic Goods Administration | 9-5-22 | Drug | Independent expert report on the risks of intentional self-poisoning with paracetamol | Regulatory | Visit Page |
USA | Food and Drug Administration | 6-5-22 | Medical Device | Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program (draft guidance) | Regulatory | Visit Page |
Europe | European Medicines Agency | 5-5-22 | Drug | Good Clinical Practice (GCP) inspection procedures – annexures updated | Clinical | Visit Page |
Europe | European Commission | 4-5-22 | Medical Device | MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR | Regulatory | Visit Page |
USA | Food and Drug Administration | 4-5-22 | Drug | FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease | Regulatory | Visit Page |
Denmark | Danish Medicines Agency | 3-5-22 | Drug | New executive order raises fees in the area of the Danish Medicines Agency | Regulatory | Visit Page |
The Philippines | Philippines FDA | 2-5-22 | Drug | Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017 | Regulatory | Visit Page |
USA | Food and Drug Administration | 2-5-22 | Drug | Importation of Prescription Drugs Final Rule Questions and Answers | Regulatory | Visit Page |
The Philippines | Philippines FDA | 2-5-22 | Drug | Guidelines on Regulatory Reliance on the Conduct of Clinical Trials in the Philippines (draft guidance) | Clinical | Visit Page |
USA | Food and Drug Administration | 2-5-22 | Biologics | Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 2-5-22 | Biologics | Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 2-5-22 | Biologics | Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components | Regulatory | Visit Page |
Europe | European Commission | 2-5-22 | Medical Device | MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | Regulatory | Visit Page |
USA | Food and Drug Administration | 2-5-22 | Drug | Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors | Safety | Visit Page |
USA | Food and Drug Administration | 2-5-22 | Drug | Risk Management Plans to Mitigate the Potential for Drug Shortages (draft guidance) | Regulatory | Visit Page |
USA | Food and Drug Administration | 2-5-22 | Drug | Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production | Regulatory | Visit Page |
The Philippines | Philippines FDA | 2-5-22 | Medical Device | Good Storage and Distribution Practices for Medical Devices (draft guidance) | Regulatory | Visit Page |
New Zealand | New Zealand Medicines and Medical Devices Safety | 2-5-22 | Drug | Review of Fees payable under the Medicines Act 1981 | Regulatory | Visit Page |
USA | Food and Drug Administration | 2-5-22 | Drug | Benefit-Risk Considerations for Product Quality Assessments (draft guidance) | CMC | Visit Page |
USA | Food and Drug Administration | 2-5-22 | Drug | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies Guidance for Industry (draft guidance) | Clinical | Visit Page |
Switzerland | The Swiss Agency for Therapeutic Products | 2-5-22 | Drug | Questions and answers on the packaging and labelling requirements for medicinal products intended to prevent or combat COVID-19 | Labeling | Visit Page |
Australia | Therapeutic Goods Administration | 29-4-22 | Drug | Proposed amendments to the Poisons Standard – ACCS, ACMS and joint ACCS/ACMS meetings | Regulatory | Visit Page |
USA | Food and Drug Administration | 29-4-22 | Drug | Crohn’s Disease: Developing Drugs for Treatment (draft guidance) | Clinical | Visit Page |
USA | Food and Drug Administration | 29-4-22 | Drug | Ulcerative Colitis: Developing Drugs for Treatment (draft guidance) | Clinical | Visit Page |
India | Central Drugs Standard Control Organisation | 28-4-22 | Drug | Procedure for regularization of FDCs | Regulatory | Visit Page |
Malaysia | Medical Device Authority | 1-4-22 | Medical Device | Guidance on the rules of classification for general medical devices | Regulatory | Visit Page |
International | The International Council for Harmonisation | 31-3-22 | Drug | Considerations with respect to future MIDD related guidelines - output from ich model-informed drug development (MIDD) | Regulatory | Visit Page |
Japan | Pharmaceuticals and Medical Devices Agency | 18-3-22 | Drug | Questions and Answers (Qs and As) on Risk Management Plan | Quality | Visit Page |
The Philippines | Philippines FDA | 3-2-22 | Vaccine | Amendment to FDA Circular No. 2020-029 entitled “Guidance on Applications for the Conduct of COVID-19 Clinical Trials | Clinical | Visit Page |
The Philippines | Philippines FDA | 13-1-21 | Drug | Revised guidelines on the cold chain Revised guidelines on the cold chain Revised guidelines on the cold chain and establishments | Labeling | Visit Page |
Malaysia | National Pharmaceutical Regulatory Agency | 1-1-21 | Medicine | Drug Registration Guidance Document (DRGD) | Registration | Visit Page |
Europe | European Medicines Agency | 1-1-21 | Drug-Device Combination | "Pilot phase for CHMP early contact with patient / consumer organisations" | Clinical | Visit Page |
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