EMA and US FDA requirements for non-clinical development of radiodiagnostics
|Pertaining to the radiodiagnostic agents, there are few changes in the non-clinical requirements between the EMA (European Medical Agency) (EMA/CHMP/SWP/686140/2018) [1] and US FDA (United States Food and Drug Administration) (Docket Number: FDA-2017-D-5297, Document ID: FDA-2017-D-5297-0007) [2]. The requirements are not the same between them; therefore, for someone who needs to register a product through … Continued