Change of Address; Abbreviated New Drug Applications; Technical Amendment
fda-drug · Food and Drug Administration · Rule · Published 2010-06-29 · Effective 2010-08-01 · 75 FR 37295
Document
Document number
2010-15711
Federal Register citation
75 FR 37295
CFR reference
21 CFR 312
Type
Rule
Action
Final rule; technical amendment.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2010-06-29
Effective date
2010-08-01
HHS docket
Docket No. FDA-2010-N-0010
Abstract
The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit abbreviated new drug applications (ANDAs) and ANDA amendments, supplements, and resubmissions. FDA is also updating the address for ANDA applicants to submit investigational new drug applications (INDs) for in vivo bioavailability and bioequivalence studies in humans that are intended to support ANDAs. This action is being taken to ensure accuracy and clarity in the agency's regulations.