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USFDA Updates on Safety Reporting Requirements for INDs and BA/BE Studies
The US Food and Drug Administration (FDA) revised its Small Entity Compliance Guide: Safety Reporting Requirements for INDs and BA/BE Studies in October 2026. The guidance helps small businesses understand safety reporting requirements for investigational drugs and biological products under Investigational New Drug (IND) applications and bioavailability (BA) and bioequivalence (BE) studies exempt from IND requirements. The revision updates the history of related guidance docu
Sharan Murugan
7 hours ago3 min read