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Generic Drug Sponsors May Discuss Alternative BE Approaches During Pre-ANDA Meetings

 
• By Kate Rawson

Teva requested the change to the draft guidance, arguing that otherwise the meetings would be “completely one-sided conversations.”

alternative approach
Final guidance removes a requirement that a PSG meeting be requested within 60 days of a revised PSG's publication. • Source: Shutterstock

ANDA product-specific guidance meetings may include discussions of alternative approaches to meeting bioequivalence standards, according to a new final guidance.

Key Takeaways

  • Final guidance on PSG meetings allows discussions of alternative BE approaches after sponsors complained that the agency would not address those issues, potentially delaying generic drug development.

  • The FDA also could state that a revised PSG does not impact an ANDA development program, although Teva questioned the language in written comments

Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA, which was released August 19, outlines the process for ANDA holders to request teleconferences and in-person meetings after the US Food and Drug Administration issues a product-specific guidance (PSG) that may affect a drug already in development. The meeting guidance replaces a draft issued in February 2023

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