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FDA (CDER)
GUIDANCE FINAL
Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and Investigators
Published: 10/19/2026Detected: 10/19/2026

Summary preview

Clarifies and standardizes safety reporting obligations for IND sponsors and for sponsors conducting BA/BE studies, aiming to ensure timely submission of safety information to FDA.

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clinical
safety
#IND safety reporting
#BA/BE studies
#adverse events
#serious adverse events
#pharmacovigilance

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