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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 22: Post-NDA Approval Regulatory Requirements

Session Chair(s)

Drusilla Scott, PhD, RAC

Drusilla Scott, PhD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., United States

  • Post-NDA Approval Obligations
  • Post-Marketing Requirements and Commitments
  • Supplements and Other Changes to an Approved Application
  • Post-Marketing Reporting
  • NDA Annual Reports
  • Other Post-Marketing Reports

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