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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...

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FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

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The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.

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