Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU.

ABSTRACT: The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer expedited regulatory approval programs for drugs with high potential patient value applicable at different stages leading to marketing authorization: (i) drug development (fast track designation (FTD), breakthrough therapy designation (BTD), regenerative medicine advanced therapy designation in the United States, and priority medicines scheme in the European Union), (ii) review of marketing authorization application (priority review in the United States and accelerated assessment in the European Union), (iii) approval of drug (accelerated approval in the United States and conditional approval in the European Union). Typical clinical development time of 76 new anticancer drugs, for which the EMA gave a p

SUBMITTER: Demirci E 

PROVIDER: S-EPMC10339697 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature