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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 6: FDA's Actions on the Original IND and Future Amendments

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

FDA’s Review of an IND
Clinical Holds: Basis for Imposition and Process for Removal