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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:45 PM - Apr 11, 2019 11:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Affairs: The IND, NDA, and Post-Marketing

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Session 16: NDA Submission, FDA Review, and Action on Applications

Session Chair(s)

Elliott Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, United States

  • Electronic Submissions
  • FDA Review of Applications and Actions on Applications
  • Amendments to an Unapproved Application
  • Reasons Applications are not Approved
  • PDUFA

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