other · Food and Drug Administration · Rule · Published 2014-12-23 · Effective 2014-12-23 · 79 FR 76888
Document
Document number
2014-29920
Federal Register citation
79 FR 76888
CFR reference
21 CFR 316
Type
Rule
Action
Notification; clarification on policy.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2014-12-23
Effective date
2014-12-23
HHS docket
Docket No. FDA-2011-N-0583
Abstract
The Food and Drug Administration (FDA) is publishing this document to clarify its policy regarding certain aspects of orphan-drug exclusivity. This document is being published because of a recent court decision interpreting provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Orphan Drug Act.