FDA Annual Public Meeting – Big Molecule Watch

On June 7, 2022, from 9:30-10:50 AM Eastern Time, FDA is hosting, virtually, its annual public meeting for public comment on Financial Transparency and Efficiency of the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA).  At the meeting, FDA will provide updates on the 5-year financial plans for these programs and provide updates on implementing resource capacity planning and modernizing FDA’s time reporting approach.  A registration link for the event can be found here and the following are links to the 2018-2022 performance goals for the programs: PDUFA VI, BsUFA II, and GDUFA II