Investigational New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
fda-drug · Food and Drug Administration · Rule · Published 2011-03-15 · Effective 2011-03-15 · 76 FR 13880
Document
Document number
2011-5946
Federal Register citation
76 FR 13880
CFR reference
21 CFR 312
Type
Rule
Action
Final rule; technical amendment.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2011-03-15
Effective date
2011-03-15
HHS docket
Docket No. FDA-2011-N-0130
Abstract
The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations and abbreviated new drug application regulations to correct inaccurate cross-references to the IND regulations and the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is being taken to ensure accuracy and clarity in the Agency's regulations.