FDA (CDER)
GUIDANCE FINAL
Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Guidance for Industry
Published: 12/15/2025Detected: 3/25/2026
Summary preview
Clarifies sponsor responsibilities for safety reporting and safety assessments for INDs and for bioavailability/bioequivalence (BA/BE) studies, with an emphasis on timely, well-documented evaluation of safety signals.
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