Investigational New Drug Applications; Technical Amendment
fda-drug · Food and Drug Administration · Rule · Published 2009-10-29 · Effective 2009-10-29 · 74 FR 55770
Document
Document number
E9-26095
Federal Register citation
74 FR 55770
CFR reference
21 CFR 312
Type
Rule
Action
Final rule; technical amendment.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2009-10-29
Effective date
2009-10-29
HHS docket
Docket No. FDA-2009-N-0464
Abstract
The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that are intended to support abbreviated new drug applications (ANDAs) should be sent directly to the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency's regulations.