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Sponsors, FDA Reviewers To Get More Flexibility Under New User Fee Program

 
• By Derrick Gingery

Next iteration of PDUFA will feature new communication plans that allow FDA and sponsors to drop mid-review meetings if desired.

PDUFA VI letter

FDA will gain more flexibility in how it can push applications through its review system in PDUFA VI, including gaining the ability to avoid some required interactions with the sponsor.

It is a subtle but important refinement of what has become known as the "Program" for NDA and BLA reviews after it was

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