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GDF2025-D2S18- Common Bioequivalence Information Requests: Tips for Facilitating the Review Process
GDF2025 – D2S17 - Case Studies of Using Alternate Reference Standard in Bioequivalence Studies
GDF2026 - Updates on Nitrosamines/ Nitrosamine Mitigation Strategies for Pharmaceuticals
How to Handle Nitrosamines in Exhibit Batch Stability
GDF2025-D2S08-Common Clinical Deficiencies in ANDAs Containing Comparative Clinical Endpoint Studies
GDF2025 - D2S07- Common Bioequivalence Deficiencies in Abbreviated New Drug Applications
AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice
Developing and Implementing Science-Based Standards in Bioequivalence Assessment
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
GDF2026 - ICH M13A High-Risk vs. Low-Risk Case Studies – Bioequivalence (BE) Implications
GDF2026 - Bioequivalence (BE) Recommendations for Bridging Pre- and Post-Mitigation Formulations
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Last Updated: October 3, 2026
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Summary
This presentation provided an overview of This presentation introduced the recent ICH M13A Guidance: The presentation provided an overview of information requests (IRs) with a description of more easily correctable deficiencies and ... This session addressed known issues and provided practical advice for managing Paramjeet Kaur from CDER's Office of Generic Drugs discusses the role of Abbreviated New Drug FDA CDER's Office of Generic Drugs (OGD) provides an overview of the revised draft guidance for industry on The ICH M13A guideline provides a framework for classifying drug products as high risk or low risk, based on biopharmaceutical ...
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