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.

virtual meeting
PDUFA VIII could be at least partially negotiated virtually. • Source: Shutterstock

CHICAGO – The biopharma industry and the US Food and Drug Administration are not ready to nix conducting prescription drug user fee reauthorization negotiations virtually once COVID-19 no longer prevents in-person gatherings.

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