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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F--BIOLOGICS
 
PART 601LICENSING
 

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.

Subpart B [Reserved]

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.

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.

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.

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.

Subpart G--Postmarketing Studies
   § 601.70 - Annual progress reports of postmarketing studies.

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.

Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note).
Source: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.

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