Issue Date: October 19, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Good Clinical Practice (GCP), Safety – Issues, Errors, and Problems
Status: Final
Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and Investigators
This guidance helps small businesses understand and comply with FDA’s safety reporting regulations for drugs and biological products under an investigational new drug application (IND), and for drugs in certain exempt bioavailability (BA) and bioequivalence (BE) studies. The guidance page was refreshed in October 2026 and now lists Center for Biologics Evaluation and Research alongside Center for Drug Evaluation and Research as a co-issuing office.
Download the Guidance Document
