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Advancing Generic Drug Development 2025

    October 7-8, 2025

     

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    Day One: Welcome & Keynote

    Welcome & Keynote (Advancing Generic Drug Development 2025)
    Lesson 1 of 1 within section Day One: Welcome & Keynote.
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    Supporting Resources – Access with FREE Enrollment (above)

    Download Agenda & Speakers Biographies
    Lesson 1 of 1 within section Supporting Resources – Access with FREE Enrollment (above). You must enroll in this course to access course content.
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    Session 1: Insights to Product-Specific Guidance for Complex Products: From Research to Standards

    SME Triage Team: Office of Pharmaceutical Quality Research & Office of Research and Standards Product-Specific Guidance Development
    Lesson 1 of 5 within section Session 1: Insights to Product-Specific Guidance for Complex Products: From Research to Standards.
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    SME Triage Team Case Study: Complex Implant Products – Excipient Sameness, Characterization and Bioequivalence Challenges
    Lesson 2 of 5 within section Session 1: Insights to Product-Specific Guidance for Complex Products: From Research to Standards.
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    Product-Specific Guidance Revisions: Update on Metered Dose Inhaler & Dry Powder Inhaler
    Lesson 3 of 5 within section Session 1: Insights to Product-Specific Guidance for Complex Products: From Research to Standards.
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    Streamlining Recommendations for Topical and Mucosal Products
    Lesson 4 of 5 within section Session 1: Insights to Product-Specific Guidance for Complex Products: From Research to Standards.
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    Session 1: Q&A Panel (Advancing Generic Drug Development 2025)
    Lesson 5 of 5 within section Session 1: Insights to Product-Specific Guidance for Complex Products: From Research to Standards. You must enroll in this course to access course content.
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    Session 2: Novel Bioequivalence Study Design Recommendations

    Biopharmaceutics Classification System Waiver Option in Product-Specific Guidances
    Lesson 1 of 6 within section Session 2: Novel Bioequivalence Study Design Recommendations.
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    Addressing Degradation Challenges in BCS Class III Biowaiver Applications Through Physiologically Based Pharmacokinetic (PBPK) Modeling
    Lesson 2 of 6 within section Session 2: Novel Bioequivalence Study Design Recommendations.
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    Using Modeling and Simulation to Correct Carryover for Long Half-Life Drug with Incomplete Washout
    Lesson 3 of 6 within section Session 2: Novel Bioequivalence Study Design Recommendations.
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    Updates and Current Landscape for Study Population Selection and Additional Mitigation Strategies in Bioequivalence Studies
    Lesson 4 of 6 within section Session 2: Novel Bioequivalence Study Design Recommendations.
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    Extrapolation of PK Bioequivalence to an Alternative Comparator due to RLD/RS Unavailability
    Lesson 5 of 6 within section Session 2: Novel Bioequivalence Study Design Recommendations.
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    Session 2: Q&A Panel and Day 1 Closing (Advancing Generic Drug Development 2025)
    Lesson 6 of 6 within section Session 2: Novel Bioequivalence Study Design Recommendations. You must enroll in this course to access course content.
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    Session 3: Common Deficiencies and Resolutions: Complex Drug Substances,Complex/Critical Excipients, and Complex Products

    Compositional Sameness for Complex Polymeric Excipients: Progress and Remaining Challenges 
    Lesson 1 of 5 within section Session 3: Common Deficiencies and Resolutions: Complex Drug Substances,Complex/Critical Excipients, and Complex Products.
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    Navigating Complexity: Key Considerations in Developing the Oral Semaglutide Product-Specific Guidance
    Lesson 2 of 5 within section Session 3: Common Deficiencies and Resolutions: Complex Drug Substances,Complex/Critical Excipients, and Complex Products.
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    Case Studies: Glatiramer Acetate Subcutaneous Injectable and Pentosan Polysulfate Oral Capsules
    Lesson 3 of 5 within section Session 3: Common Deficiencies and Resolutions: Complex Drug Substances,Complex/Critical Excipients, and Complex Products.
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    Comparative Physicochemical Characterization of Iron Products
    Lesson 4 of 5 within section Session 3: Common Deficiencies and Resolutions: Complex Drug Substances,Complex/Critical Excipients, and Complex Products.
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    Session 3: Q&A Panel (Advancing Generic Drug Development 2025)
    Lesson 5 of 5 within section Session 3: Common Deficiencies and Resolutions: Complex Drug Substances,Complex/Critical Excipients, and Complex Products. You must enroll in this course to access course content.
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    Session 4: Nitrosamines: Known Issues and Practical Advice

    Nitrosamine Impacted Drug Products Containing BCS IV Drug Substances
    Lesson 1 of 4 within section Session 4: Nitrosamines: Known Issues and Practical Advice.
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    Addressing Potential Pitfalls in Nitrosamine Risk Assessment and Control
    Lesson 2 of 4 within section Session 4: Nitrosamines: Known Issues and Practical Advice.
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    Pharm/Tox Considerations for the Safety Evaluation of Nitrosamine Impurities
    Lesson 3 of 4 within section Session 4: Nitrosamines: Known Issues and Practical Advice.
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    Session 4: Q&A Panel and Day Two Closing (Advancing Generic Drug Development 2025)
    Lesson 4 of 4 within section Session 4: Nitrosamines: Known Issues and Practical Advice. You must enroll in this course to access course content.
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    About

    In this 2-day workshop, FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Dissect complex scientific challenges in abbreviated new drug applications (ANDAs) alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues related to product-specific guidance development, as well as pre-ANDA and ANDA meeting discussions. The workshop will also highlight innovative science and cutting-edge methodologies in generic drug development.

    Topics

    • Research and methodologies to support guidance development on complex generic products including implant, inhalation, and topical products
    • Innovative methodologies and design recommendations for demonstrating therapeutic equivalence
    • Common regulatory challenges and solutions for generic products with complex drug substances, excipients, and formulations
    • Known issues and practical strategies for addressing nitrosamine contamination in pharmaceutical products

    Course Information

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