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U.S. Department of Health and Human Services

Drugs

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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

In September 2010, the Food and Drug Administration issued final regulations addressing the safety reporting requirements for investigational new drug applications (INDs) found in 21 CFR part 312 and for bioavailability and bioequivalence studies found in 21 CFR part 320. 

This final rule is expected to improve the quality of safety reports submitted to FDA, thereby enhancing the safety of patients in clinical trials. The final rule lays out clear definitions and standards so that critical safety information about investigational new drugs will be accurately and rapidly reported to the agency, minimizing uninformative reports and enhancing reporting of meaningful, interpretable information.