other · Food and Drug Administration · Rule · Published 2013-06-12 · Effective 2013-08-12 · 78 FR 35117
Document
Document number
2013-13930
Federal Register citation
78 FR 35117
CFR reference
21 CFR 316
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2013-06-12
Effective date
2013-08-12
HHS docket
Docket No. FDA-2011-N-0583
Abstract
The Food and Drug Administration (FDA) is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.