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The New Drug Approval Process: NDA Submission and Review

Recognize the content and organization of a full New Drug Application. Become familiar with: User fees and goals under the Prescription Drug User Fee Act (PDUFA); Expedited review programs; and Best practices when interacting with FDA

Daniela Drago, Partner, NDA Partners LLC

This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in April 2025.

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