Industry Sources: 'Cures,' PDUFA Entirely Separate But Inform Each Other

September 4, 2015 at 2:28 PM
FDA officials repeatedly have said some provisions of the House's 21st Century Cures bill would be better left to the Prescription Drug User Fee Act (PDUFA) reauthorization process without giving specifics, but sources say while the two inform each other industry is addressing each separately. Cures deals with agency policy, while PDUFA is limited to FDA's application review process, industry sources note. How they intersect, industry sources told reporters at a background briefing Wednesday (Sept. 2), is that large policy...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.