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Human Subjects Division (HSD)

Regulatory Updates

FDA: Guidance - Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies

Jun 20, 2011 at 12:00am
This document provides guidance to sponsors and investigators on enforcement of FDA's final rule, "Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans" (75 FR 59935, September 29, 2010). This guidance contains information regarding the Agency's intent to exercise enforcement discretion regarding the reporting requirements in the final rule until September 28, 2011. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM257976.pdf