TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F - BIOLOGICS
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.
§ 601.27 - 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.
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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), sec 7002(e), Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N, Pub. L. 116-94, 133 Stat. 3127.
Source: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.
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