Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

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Session 13: Postmarketing Safety Regulations – US

Session Chair(s)

Jill W. Buckley, PharmD

Adjunct Assistant Professor

Rutgers, the State University of New Jersey, United States

This session will cover the FDA requirements for safety reporting for marketed products including prescription products, Abbreviated applications and complaint files as well as nonprescription (OTC) and dietary supplements.

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Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Session 13: Postmarketing Safety Regulations – US

Session Chair(s)

Jill W. Buckley, PharmD

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