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HHS - 21 CFR PART 316

ORPHAN DRUGS

active, Most Current
Organization: HHS
Publication Date: 1 April 2023
Status: active
Page Count: 13
scope:

Scope of this part.

(a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions, including biological products and antibiotics. This part sets forth the procedures and requirements for:

(1) Submissions to FDA of:

(i) Requests for recommendations for investigations of drugs for rare diseases or conditions;

(ii) Requests for designation of a drug for a rare disease or condition; and

(iii) Requests for gaining exclusive approval for a drug for a rare disease or condition.

(2) Allowing a sponsor to provide an investigational drug under a treatment protocol to patients who need the drug for treatment of a rare disease or condition.

(b) This part does not apply to food, medical devices, or drugs for veterinary use.

(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

[57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35132, June 12, 2013]

Document History

21 CFR PART 316
April 1, 2023
ORPHAN DRUGS
Scope of this part. (a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions,...
April 1, 2021
ORPHAN DRUGS
Scope of this part. (a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions,...
April 1, 2020
ORPHAN DRUGS
Scope of this part. (a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions,...
April 1, 2019
ORPHAN DRUGS
Scope of this part. (a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions,...
April 1, 2018
ORPHAN DRUGS
Scope of this part. (a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions,...
April 1, 2017
ORPHAN DRUGS
Scope of this part. (a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions,...
April 1, 2016
ORPHAN DRUGS
(a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions, including biological...
April 1, 2015
ORPHAN DRUGS
Scope of this part. (a)This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions,...
April 1, 2014
ORPHAN DRUGS
(a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions, including biological...
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