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

 
• By Derrick Gingery

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

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