PDUFA VI: Industry Ready For 'Hard Sell' To Keep Agreement Intact
Biopharma industry is preparing for the unwelcome possibility that the new Congress and Trump Administration will seek to revisit provisions in the negotiated agreement for the US FDA user fee program's reauthorization.
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At FDLI, both US FDA acting Commissioner Stephen Ostroff and BIO’s Kay Holcombe strike note of anticipating positive outcomes for FDA, despite current political and regulatory uncertainties. FDA has been through challenges before, and “we have come through them even stronger," Ostroff assures meeting.
House Energy and Commerce Committee Democrat says few in-depth member talks about the user fee bill have taken place because of focus on ACA repeal and replacement.
Legislation would create a potential second priority review pathway for generics, as well as another priority review voucher program, but may not be as enticing as GDUFA II proposal.