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Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

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.
§601.27
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.

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