The FDA is preparing for the renewal of four of its biggest user fee programs in FY2022: PDUFA, MDUFA, GDUFA and BsUFA. The keystone programs facilitate the efficient review of pharmaceuticals and biopharmaceuticals, medical devices and diagnostics, generic drugs and biosimilars, respectively.

But how are these programs likely to change in the year ahead, and what should industry be paying attention to? In this webinar, AgencyIQ’s research team will analyze the latest information available from commitment letters, negotiating meeting minutes, public statements and POLITICO reporting to describe the state of the negotiations, what industry can expect to see next and the role that Congress is likely to play in months ahead.