# Policy on Orphan-Drug Exclusivity; Clarification
> **Food and Drug Administration** · Notification; clarification on policy. · Published 2014-12-23 · Effective 2014-12-23 · 79 FR 76888
## Document
- **Document number:** 2014-29920
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 79 FR 76888
- **CFR reference:** 21 CFR 316
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2014/12/23/2014-29920/policy-on-orphan-drug-exclusivity-clarification)
---
*AI Analytics · CC0 1.0*