Module 1 2021

Marketing Application - FDA Review

• When to file NDA: File at completion of all 3 phases (with exception of accelerated approval) − 21 CFR Part 314 (Application for FDA Approval to Market a New Drug) − 21 CFR Part 601 (Licensing) • FDA assembles the Review Team with review schedule shared with sponsor • FDA Advisory Committee – To provide independent advice that will contribute to the quality of the agency’s regulatory decision- making and lend credibility to the product review process

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Marketing Application - FDA Review Process

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