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The New Drug Approval Process: NDA Submission and Review

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Recorded November 15, 2023 | On-Demand Webinar
Access to recordings of virtual introductory courses is limited to one year from the date of purchase as we update programs annually.

• 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
– Best practices when interacting with FDA

This session was recorded as part of FDLI’s virtual Introduction to Drug Law and Regulation course in November 2023.

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