New Drug Applications and Abbreviated New Drug Applications; Editorial Amendments
fda-drug · Food and Drug Administration · Rule · Published 1997-08-15 · Effective 1997-08-15 · 62 FR 43639
Document
Document number
97-21649
Federal Register citation
62 FR 43639
CFR reference
21 CFR 314
Type
Rule
Action
Final rule.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
1997-08-15
Effective date
1997-08-15
Abstract
The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to reflect a reorganization in the Center for Drug Evaluation and Research (CDER). This action will improve the accuracy of the regulations.