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GDF2026 - Addressing Patent and Exclusivity Requirements – Regulatory Reminders
GDF2026 - Recent Trends in Pharmaceutical Freeze-Drying and Control Strategies
GDF2026 - Standardized Principles Used to Determine Maximum Daily Dose
Generic Drugs Forum (GDF) 2026 - Day 1
GDF2026 - Regulatory Review Process for Type II Secondary DMFs
GDF2026 - ICH M13A High-Risk vs. Low-Risk Case Studies – Bioequivalence (BE) Implications
GDF2026 - Bioequivalence (BE) Recommendations for Bridging Pre- and Post-Mitigation Formulations
Generic Drugs Forum (GDF) 2026 - Day 2
GDF2026 - Product-Specific Guidances (PSGs) in Action – Key Lessons and Common Questions
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Last Updated: October 3, 2026
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Summary
This session discusses the common manufacturing process related This presentation highlighted common This session provided reminders concerning the patent, exclusivity, and legal information that ANDA applicants are required to ... This presentation discussed the role of the Maximum Daily Dose (MDD) as it pertains to generic drug assessment and share some ... This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment ... The ICH M13A guideline provides a framework for classifying drug products as high risk or low risk, based on biopharmaceutical ... This presentation underscored key lessons, address frequently asked questions, and clarify common misunderstandings related ...
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