Part 601 — Licensing
Current through Sep 8, 2026
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.
Cross References:
For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR 12.21-12.23. For U.S. Postal Service regulations relating to the admissibility to the United States mails see parts 124 and 125 of the Domestic Mail Manual, that is incorporated by reference in 39 CFR part 111.
Sections
- § 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.
- § 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.
- § 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.
- § 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.
- § 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.
- § 601.70 Annual progress reports of postmarketing studies.
- § 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.