The New Drug Approval Process: NDA Submission and Review
Review the content and organization of a full New Drug Application. Become familiar with user fees and goals under the Prescription Drug User Fee Act, expedited review programs, (PDUFA) and best practices when interacting with FDA.
Kyle Y. Faget, Of Counsel, Foley & Lardner LLP
This session was recorded as part of FDLI’s Virtual Introduction to Drug Law and Regulation Course in April 2020.
- +$100 for nonmembers
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