# Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
> **Food and Drug Administration** · Final rule. · Published 2010-09-29 · Effective 2011-03-28 · 75 FR 59935
## Document
- **Document number:** 2010-24296
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 75 FR 59935
- **CFR reference:** 21 CFR 312
- **Publication date:** 2010-09-29
- **Effective date:** 2011-03-28
- **HHS docket:** Docket No. FDA-2000-N-0108
## Abstract

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2010/09/29/2010-24296/investigational-new-drug-safety-reporting-requirements-for-human-drug-and-biological-products-and)
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