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Session 7: IND Amendments and Maintenance
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
- Amendments to the IND
- Annual Reports/DSUR
- Noncommercial INDs
- IND Administrative Actions
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.