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Seaport Hotel

Aug 12, 2019 7:45 AM - Aug 15, 2019 5:00 PM

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.

Back to Agenda

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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