Archive for May 2022

The U.S. House Energy and Commerce (E&C) Health Subcommittee on Wednesday advanced to the full committee legislation reauthorizing user fee programs, including PDUFA and MDUFA. The legislation, H.R. 7667, the Food and Drug Amendment Act, passed 30-0 on a bipartisan vote with provisions to increase clinical trial diversity, modify the accelerated approval pathway and promote generics. On the…