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Last Updated: September 24, 2026
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This session provided an overview of the This presentation provided a background refresher on the Generic Drug User Fee Amendments (GDUFA III) Commitment Letter ... This session highlighted major deficiencies and other common issues identified during the filing review of ANDAs. The systematic ... This presentation focused on strategies to demonstrate bioequivalence of products reformulated due to nitrosamine concerns. This presentation underscored key lessons, address frequently asked questions, and clarify common misunderstandings related ... This session discussed the risk-based regulatory review process for the acceptance of Type II secondary DMFs for the The presentation provided an overview on the U.S. FDA Product-Specific Guidance (PSG) program including how and when ... This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment ... This session covered how and when updates to the Orange Book are made and review how to utilize the Orange Book data files. This presentation explained the scientific and regulatory rationale underlying key recommendations in PSGs for complex non-oral ... The seventh Q&A panel of the Generic Drugs Forum (
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