# Adequate and Well-Controlled Studies for Investigational Use and Approval of New Animal Drugs
> **Food and Drug Administration** · Final rule. · Published 1998-03-05 · Effective 1998-04-06 · 63 FR 10765
## Document
- **Document number:** 98-5675
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 10765
- **CFR reference:** 21 CFR 514
- **Publication date:** 1998-03-05
- **Effective date:** 1998-04-06
- **HHS docket:** Docket No. 97N-0141
## Abstract

The Food and Drug Administration (FDA), as directed by the Animal Drug Availability Act of 1996 (ADAA), is amending its regulations governing new animal drug applications to further define the term ``adequate and well-controlled studies.'' The purpose of this final rule is to further define ``adequate and well controlled'' to require that field investigations be designed and conducted in a scientifically sound manner, taking into account practical conditions in the field and differences between field conditions and laboratory conditions.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/03/05/98-5675/adequate-and-well-controlled-studies-for-investigational-use-and-approval-of-new-animal-drugs)
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