US FDA/Industry Thinking PDUFA VIII Could Be A Hybrid Negotiation
Virtual meetings proved successful, and could be allowed again when the next round of user fee reauthorization talks convene.
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CBER Director Peter Marks hopes to run pilot programs that could convince Congress or industry to provide more funding that would enable FDA to offer pandemic-level communication with sponsors in 'normal' times.
Labeling changes for the pain products remain in active discussion, the US FDA commissioner tells the Senate Health, Education, Labor and Pensions Committee during a hearing on the monkeypox outbreak.
The policy allowing the FDA to work past a goal date could be used to deal with the generic delaying tactic, but an industry expert said other avenues to quickly dispatch labeling issues may be more appropriate.