Counsel Stack
|
Law
Browse
Pricing
Counsel Stack
API Docs
Home
/
CFR
/
Title 21
/
Part 316
FEDERAL · 21 CFR
Part 316 — Orphan Drugs
24 sections · Title 21: Food and Drugs
§ 316.1
Scope of this part.
§ 316.2
Purpose.
§ 316.3
Definitions.
§ 316.4
Address for submissions.
§ 316.10
Content and format of a request for written recommendations.
§ 316.12
Providing written recommendations.
§ 316.14
Refusal to provide written recommendations.
§ 316.20
Content and format of a request for orphan-drug designation.
§ 316.21
Verification of orphan-drug status.
§ 316.22
Permanent-resident agent for foreign sponsor.
§ 316.23
Timing of requests for orphan-drug designation; designation of already approved drugs.
§ 316.24
Deficiency letters and granting orphan-drug designation.
§ 316.25
Refusal to grant orphan-drug designation.
§ 316.26
Amendment to orphan-drug designation.
§ 316.27
Change in ownership of orphan-drug designation.
§ 316.28
Publication of orphan-drug designations.
§ 316.29
Revocation of orphan-drug designation.
§ 316.30
Annual reports of holder of orphan-drug designation.
§ 316.31
Scope of orphan-drug exclusive approval.
§ 316.34
FDA recognition of exclusive approval.
§ 316.36
Insufficient quantities of orphan drugs.
§ 316.40
Treatment use of a designated orphan drug.
§ 316.50
Guidance documents.
§ 316.52
Availability for public disclosure of data and information in requests and applications.