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About

As a continuation from the 2018 workshop on complex generic drug products, the goal of this science-focused workshop is to communicate to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development. FDA will link GDUFA science and research on complex drug products to product-specific guidance development, discuss pre-ANDA meetings and review, and examine various areas of complex product science.

Complex drug products often have features that make them harder to develop as generics under traditional approaches. These challenges can mean these ANDAs may undergo more assessment cycles than other ANDAs for non-complex generic drug products before receiving FDA approval, which, in turn, may result in limited competition. That is why the FDA has made facilitating the development and approval of complex generic drug products a major focus of the FDA’s Drug Competition Action Plan, which is aimed at encouraging generic drug competition in an effort to help reduce drug prices. It is our hope that the Complex Generic Drug Product Development Workshop will help facilitate the development and approval of ANDAs for complex generic drug products and the introduction of more generic medicines to the complex drug marketplace.

Topics Covered

• Pre-ANDA program update
• FDA’s inactive ingredient database: improvements on the path to 2020
• Scientific and regulatory advances for generic topical and transdermal drug product development
• Characterization of complex injectable active pharmaceutical ingredient API and formulations
• Bioequivalence approaches for complex injectable API and formulations
• Complex drug-device combination products – injectable drug products
• Complex drug-device combination products – orally-inhaled and nasal drug products
• Quantitative methods and modeling-informed regulatory decision making

Intended Audience

Scientists, researchers, and regulatory affairs professionals who work on or are interested in working on the development of complex generic drugs.

Learning Objectives

After this workshop, participants will be able to:

• Explain various mechanisms and processes that industry can use to obtain advice from the FDA to facilitate complex generic drug product development; and
• Summarize new developments in science, guidance, and review experience for specific types of complex generic drug products.

FDA Resources

• Generic Drug Science and Research
• Guidance for Industry, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
• Draft Guidance for Industry, Controlled Correspondence Related to Generic Drug Development
• Draft Guidance for Industry, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA
• Product-Specific Guidances for Generic Drug Development
• Upcoming Product-Specific Guidances for Complex Generic Drug Product Development
• Draft Guidance for Industry, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products - Quality Considerations
• Guidance for Industry, Safety Considerations for Product Design to Minimize Medication Errors

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