New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
fda-drug · Food and Drug Administration · Rule · Published 2009-03-06 · Effective 2009-03-06 · 74 FR 9765
Document
Document number
E9-4813
Federal Register citation
74 FR 9765
CFR reference
21 CFR 314
Type
Rule
Action
Final rule; technical amendment.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2009-03-06
Effective date
2009-03-06
HHS docket
Docket No. FDA-2009-N-0099
Abstract
The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to update agency contacts for patent information and patent notifications and to correct an inaccurate cross-reference. This action is being taken to ensure accuracy and clarity in the agency's regulations.