PDUFA Renewal Negotiations Nearly Complete, With CBER Slated For Major Resource Increase

While the prescription drug user fee agreement between industry and the US FDA is almost done, generic renewal talks remain ongoing, and biosimilar talks have not started.

Negotiate Agreement Negotiation Speedometer Measure Results 3d Illustration
PDUFA VII negotiators recently met with Acting FDA Commissioner Janet Woodcock to offer an update on their progress. • Source: Shutterstock

Prescription drug user fee reauthorization negotiations are nearly complete, as final touches are being made to commitments for the program’s next five years.

Talks have been ongoing since 15 September 2020 to continue the program beyond its 30 September 2022 sunset. Richard Pops,...

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