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Confirmatory Trials: Industry Wants Timely Protocol Feedback, More Clarity On ‘Due Diligence’

 
• By Sue Sutter

Consumer and academic group comments on accelerated approval and confirmatory trial guidances say the proposed criteria for determining when a study is underway are too vague.

Feedback
Industry wants timely FDA feedback on confirmatory trial protocols. (Shutterstock)
Key Takeaways
  • PhRMA wants FDA feedback on confirmatory study protocols within 60 days and says the agency should be willing to grant early meetings to discuss study...

Industry comments on two recent US Food and Drug Administration guidance documents on accelerated approval seek clear timelines for agency feedback on confirmatory study protocols and a better understanding of...

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