Published on
March 10, 2022
- 17:01 GMT
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
Docket Number: FDA-2003-D-0378 Issued by: Guidance Issuing Office Center for Devices and Radiological Health Center for Biologics Evaluation and Research The Medical Device User Fee Amendments of 2022 (MDUFA V) amended the Federal Food, Drug, and Cosmetic …
Distribution channels:
Healthcare & Pharmaceuticals Industry
