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