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ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

Wish list
The generic drug industry shared its wish list for GDUFA IV. (Shutterstock)
Key Takeaways
  • Complex generics, transparency and clearer communication opportunities are likely to be early targets for the GDUFA IV negotiations.

A dedicated program to boost complex generics, more transparency into the abbreviated new drug application review process, and clearer opportunities for communication with US Food and Drug Administration staff are among industry’s “asks” for the next iteration of the generic drug user fee program.

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