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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 2: The IND in Detail - Modules 1, 2, and 5

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

  • IND Item 1: Form FDA 1571
  • IND Item 2: Table of Contents
  • IND Item 3: Introductory Statement
  • IND Item 4: General Investigation Plan
  • IND Item 5: Investigator’s Brochure
  • IND Item 6: Protocols

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