Regulatory Affairs: The IND, NDA, and Post-Marketing

Attend this live, virtual training course to learn about FDA regulations and expectations for the content, submission and review of INDs and NDAs, and the importance of regulatory strategy.

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Introduction to Regulation of Drugs and Biologics in the United States: Pre-Course Module

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

President, Regulatory Advantage, LLC, United States

Kevin Daniel Healy, PHD

Senior Vice President Regulatory Affairs, Entrada Therapeutics, United States

Introduction to Regulation of Drugs and Biologics in the United States: Pre-Course Module

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Regulatory Affairs: The IND, NDA, and Post-Marketing

Introduction to Regulation of Drugs and Biologics in the United States: Pre-Course Module

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Kevin Daniel Healy, PHD

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