About GPO   |   Newsroom/Media   |   Congressional Relations   |   Inspector General   |   Careers   |   Contact   |   askGPO   |   Help  
 
Home   |   Customers   |   Vendors   |   Libraries  
The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government produced by the Office of the Federal Register (OFR) and the Government Publishing Office.


Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF

Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.

Purchase individual CFR titles from the U.S. Government Online Bookstore.

Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.

[1]
 
 

Electronic Code of Federal Regulations

Electronic Code of Federal Regulations

e-CFR data is current as of April 23, 2015

Title 21Chapter ISubchapter FPart 601


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER F—BIOLOGICS

PART 601—LICENSING

rule

Subpart A—GENERAL PROVISIONS

§601.2
Applications for biologics licenses; procedures for filing.
§601.3
Complete response letter to the applicant.
§601.4
Issuance and denial of license.
§601.5
Revocation of license.
§601.6
Suspension of license.
§601.7
Procedure for hearings.
§601.8
Publication of revocation.
§601.9
Licenses; reissuance.
rule

Subpart B—[RESERVED]

rule

Subpart C—BIOLOGICS LICENSING

§601.12
Changes to an approved application.
§601.14
Regulatory submissions in electronic format.
§601.15
Foreign establishments and products: samples for each importation.
§601.20
Biologics licenses; issuance and conditions.
§601.21
Products under development.
§601.22
Products in short supply; initial manufacturing at other than licensed location.
§601.25
Review procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use.
§601.26
Reclassification procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use.
§601.27
Pediatric studies.
§601.28
Annual reports of postmarketing pediatric studies.
§601.29
Guidance documents.
rule

Subpart D—DIAGNOSTIC RADIOPHARMACEUTICALS

§601.30
Scope.
§601.31
Definition.
§601.32
General factors relevant to safety and effectiveness.
§601.33
Indications.
§601.34
Evaluation of effectiveness.
§601.35
Evaluation of safety.
rule

Subpart E—ACCELERATED APPROVAL OF BIOLOGICAL PRODUCTS FOR SERIOUS OR LIFE-THREATENING ILLNESSES

§601.40
Scope.
§601.41
Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
§601.42
Approval with restrictions to assure safe use.
§601.43
Withdrawal procedures.
§601.44
Postmarketing safety reporting.
§601.45
Promotional materials.
§601.46
Termination of requirements.
rule

Subpart F—CONFIDENTIALITY OF INFORMATION

§601.50
Confidentiality of data and information in an investigational new drug notice for a biological product.
§601.51
Confidentiality of data and information in applications for biologics licenses.
rule

Subpart G—POSTMARKETING STUDIES

§601.70
Annual progress reports of postmarketing studies.
rule

Subpart H—APPROVAL OF BIOLOGICAL PRODUCTS WHEN HUMAN EFFICACY STUDIES ARE NOT ETHICAL OR FEASIBLE

§601.90
Scope.
§601.91
Approval based on evidence of effectiveness from studies in animals.
§601.92
Withdrawal procedures.
§601.93
Postmarketing safety reporting.
§601.94
Promotional materials.
§601.95
Termination of requirements.

Need assistance?