New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
fda-drug · Food and Drug Administration · Rule · Published 2009-07-24 · Effective 2009-07-24 · 74 FR 36604
Document
Document number
E9-17680
Federal Register citation
74 FR 36604
CFR reference
21 CFR 314
Type
Rule
Action
Final rule; technical amendment.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2009-07-24
Effective date
2009-07-24
HHS docket
Docket No. FDA-2009-N-0316
Abstract
The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to correct the address for the Orange Book Staff in the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency's regulations.