Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

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Session 6: FDA Guidance for Industry on Safety Reporting

Session Chair(s)

Jill W. Buckley, PharmD

Adjunct Assistant Professor

Rutgers, the State University of New Jersey, United States

This session will review the FDA guidelines on safety reporting that provide recommendations for how sponsors of INDs can identify and evaluate important safety information as well as recommendations for a systematic approach to IND safety reporting.

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Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Session 6: FDA Guidance for Industry on Safety Reporting

Session Chair(s)

Jill W. Buckley, PharmD

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