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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 16: NDA Submission, FDA Review, and Action on Applications

Session Chair(s)

Drusilla Scott, PhD, RAC

Drusilla Scott, PhD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., United States

Electronic Submissions
FDA Review of Applications and Actions on Applications
Amendments to an Unapproved Application
Reasons Applications are not Approved
PDUFA

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