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US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

Arrows hitting targets
FDA's Office of Generic Drugs understands the importance of hitting the mark on user fee goal dates. (Shutterstock)
Key Takeaways
  • The Office of Generic Drugs is committed to meeting user fee goal dates despite layoffs and restructuring, FDA officials pledged during the annual Generic Drugs Forum.
  • Former Office of Regulatory Operations Director Ted Sherwood said reviewers hope to approve an application, not just meet the deadline.
  • OGD Deputy Director Darby Kozak included starting the GDUFA IV negotiation process on his closing list of 2025 plans for OGD.

The US Food and Drug Administration’s generic drug review group “is fully committed to doing everything possible to continue to advance the program and continue to meet all the of...

The annual meeting was held during an unprecedented period of strain on the FDA amid an ongoing restructuring plan. Recent layoffs have raised questions about the agency’s ability to

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