Overview of Gdf2026 Using Fda%e2%80%99s Inactive Ingredient Database Iid Best Practices And Considerations
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GDF2026 - Common Bioequivalence (BE) Study Design Deficiencies and How to Avoid Them
GDF2025 - D1S14 - How to Leverage the Inactive Ingredient Database and Safety Justification
GDF2026 - Best Practices for Safety Assessment of Nitrosamines in Generic Drugs
GDF2026 - Orange Book: How Drug Product Listings are Added, Updated, and Maintained
GDF2026 - Complex Drug Products – Quality Considerations for Generic Oligonucleotides
Generic Drugs Forum (GDF) 2026 - Day 1
GDF2025 - D1S13 - Assessment of Inactive Ingredients in Generic Drug Applications
GDF2026 - Quality and Safety Assessment of Extractables/Leachables in Generic Drug Products
GDF2026 - Bioanalysis of Endogenous Drugs Using Surrogate Matrix Approach in ANDAs
GDF2026 - Data Integrity in ANDA Applications
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Last Updated: October 3, 2026
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Summary
This presentation explained how to Susan Zuk from the Office of Pharmaceutical Quality provides an update on how the This presentation highlighted common deficiencies observed in bioequivalence (BE) study designs and explains how they can ... This session provided an overview of the This presentation provided current expectations for setting acceptable intake (AI) limits for nitrosamine impurities and discuss ... This session covered how and when updates to the Orange Book are made and review how to utilize the Orange Book This session discussed generic oligonucleotide drug product sameness evaluation and control strategies from quality perspective. This premier event brings together In most ANDAs for endogenous drugs, bioanalytical method
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