FDA Submits PDUFA Proposal to Congress
The Prescription Drug User Fee Act (PDUFA) expires at the end of September; the FDA submitted their request for program reauthorization to Congress.
Current program recommendations include efforts to expand safety and monitoring with particular emphasis on post-marketing surveillance, funds to upgrade the program’s information technology infrastructure with an eye on adopting an electronic system for drug review, and a new program to evaluate television advertising of pharmaceuticals.
The FDA developed the proposal and then held an open session for comments. One particular change that resulted from the external review was to limit the time frame for urgent FDA review sessions to a target of within 30 days from the time of request.
The new program will increase collected fees to $392.8 million, $87.4 mission more than the previous iteration of the Act.
See also:
- Medical Device Manufacturers Wary of Pharmas
- FDA Commissioner Addresses Financial Conflict of Interest
- FDA Rolls Out Plan for Better Postmarket Device Monitoring
April 2, 2007 Related topics: Legal & legislative