Change of Address; Biologics License Applications; Technical Amendment
other · Food and Drug Administration · Rule · Published 2013-04-02 · Effective 2013-04-02 · 78 FR 19585
Document
Document number
2013-07578
Federal Register citation
78 FR 19585
CFR reference
21 CFR 600
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2013-04-02
Effective date
2013-04-02
HHS docket
Docket No. FDA-2013-N-0011
Abstract
The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit biologics license applications (BLAs) and BLA amendments and supplements regulated by the Center for Drug Evaluation and Research (CDER). This action is being taken to ensure accuracy and clarity in the Agency's regulations.