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Sheraton Philadelphia University City

2019 年 10 月 14 日 7:45 上午 - 2019 年 10 月 17 日 5:00 下午

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 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