# Records and Reports Concerning Experience With Approved New Animal Drugs
> **Food and Drug Administration** · Interim final rule; opportunity for public comment. · Published 2002-02-04 · Effective 2002-08-05 · 67 FR 5046
## Document
- **Document number:** 02-2549
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 67 FR 5046
- **CFR reference:** 21 CFR 211
- **Publication date:** 2002-02-04
- **Effective date:** 2002-08-05
- **HHS docket:** Docket No. 88N-0038
## Abstract

The Food and Drug Administration (FDA) is amending its requirements for records and reports of adverse experiences and other information for approved new animal drugs. This interim final rule more clearly defines the kinds of information to be maintained and submitted by new animal drug applicants for a new animal drug application (NADA) or an abbreviated new animal drug application (ANADA). In addition, the interim final rule revises the timing and content of certain reports to enhance their usefulness. The regulation will provide for protection of public and animal health and reduce unnecessary recordkeeping and reporting requirements.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2002/02/04/02-2549/records-and-reports-concerning-experience-with-approved-new-animal-drugs)
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