# Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports
> **Food and Drug Administration** · Final rule. · Published 2000-10-30 · Effective 2001-02-27 · 65 FR 64607
## Document
- **Document number:** 00-27731
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 64607
- **CFR reference:** 21 CFR 314
- **Publication date:** 2000-10-30
- **Effective date:** 2001-02-27
- **HHS docket:** Docket No. 99N-1852
## Abstract

The Food and Drug Administration (FDA) is revising the requirements for annual postmarketing status reports for approved human drug and biological products, and is requiring applicants to submit annual status reports for certain postmarketing studies of licensed biological products. This rule describes the types of postmarketing studies covered by these status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. This action will implement the Food and Drug Administration Modernization Act of 1997 (FDAMA).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/10/30/00-27731/postmarketing-studies-for-approved-human-drug-and-licensed-biological-products-status-reports)
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