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AGENDA

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of the ways OGD supports generic drug regulatory activities is through international engagements.

In this webinar, FDA will discuss and provide updates on FDA and EMA’s Parallel Scientific Advice (PSA) Pilot Program for complex generics/hybrid products, address currently available international engagement opportunities, host a panel discussion on topics pertinent to the generic drug industry, and answer questions during live Q&A sessions with FDA and other global regulatory experts.

INTENDED AUDIENCE

• Members of global regulatory agencies including regulatory reviewers
• Generic drug industry including current and prospective applicants who are interested in submitting an application for a generic drug
• Consultants focused on bioequivalence, and clinical research coordinators

TOPICS COVERED

• FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generics/Hybrid Products
• Generic Drug Cluster
• International Collaboration Among Regulatory Agencies

AGENDA

FDA RESOURCES

• FDA Office of Generic Drugs Global Generic Drug Affairs
• FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products