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Sheraton Philadelphia University City

14 oct 2019 7:45 a.m. - 17 oct 2019 5:00 p.m.

3549 Chestnut Street, Philadelphia, PA 19104

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

Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.

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

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, 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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