Substantial Evidence of Effectiveness of New Animal Drugs
other · Food and Drug Administration · Rule · Published 1999-07-28 · Effective 1999-08-27 · 64 FR 40746
Document
Document number
99-19193
Federal Register citation
64 FR 40746
CFR reference
21 CFR 514
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1999-07-28
Effective date
1999-08-27
HHS docket
Docket No. 97N-0435
Abstract
The Food and Drug Administration (FDA), as directed by the Animal Drug Availability Act of 1996 (ADAA), is amending its new animal drug regulations to further define the term ``substantial evidence.'' The purpose of this final rule is to encourage the submission of new animal drug applications (NADA's) and supplemental NADA's for single ingredient and combination new animal drugs. The final rule also encourages dose range labeling.