Adequate and Well-Controlled Studies for Investigational Use and Approval of New Animal Drugs
other · Food and Drug Administration · Rule · Published 1998-03-05 · Effective 1998-04-06 · 63 FR 10765
Document
Document number
98-5675
Federal Register citation
63 FR 10765
CFR reference
21 CFR 514
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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.