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
    • Best practices when interacting with FDA

Elizabeth Mulkey, Associate, Goodwin Procter LLP

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

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