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Seaport Hotel

2019 年 08 月 12 日 7:45 上午 - 2019 年 08 月 15 日 5:00 下午

One Seaport Lane, Boston, MA 02210

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.

Session 19: Interactions with FDA - Part 2

Session Chair(s)

Drusilla  Scott, PhD, RAC

Drusilla Scott, PhD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., United States

  • Principles for Communicating with FDA
  • Meeting Etiquette
  • Resolving Issues or Disputes with FDA
  • Summary on Interacting with FDA
  • Advisory Committee Meetings
  • Advisory Committee Meeting Video

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