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Sheraton Philadelphia University City

Oct 14, 2019 7:45 AM - Oct 17, 2019 5:00 PM

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.

Back to Agenda

Session 14: The NDA: Planning, Content, Types of NDAs/BLAs, and Exclusivity

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

  • Getting from the IND to the NDA
  • NDA Data Sources and Specific Populations
  • Types of NDAs
  • BLAs: Biologics and Biosimilars
  • Combination Products and OTC Drugs
  • Patent Term Restoration and Exclusivity

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