Title 21

PART 601

Part 601 - Licensing

PART 601 - LICENSING 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. 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.

• 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.

21:7.0.1.1.2.1	SUBPART A	Subpart A - General Provisions
21:7.0.1.1.2.1.1.1	SECTION 601.2	601.2 Applications for biologics licenses; procedures for filing.
21:7.0.1.1.2.1.1.2	SECTION 601.3	601.3 Complete response letter to the applicant.
21:7.0.1.1.2.1.1.3	SECTION 601.4	601.4 Issuance and denial of license.
21:7.0.1.1.2.1.1.4	SECTION 601.5	601.5 Revocation of license.
21:7.0.1.1.2.1.1.5	SECTION 601.6	601.6 Suspension of license.
21:7.0.1.1.2.1.1.6	SECTION 601.7	601.7 Procedure for hearings.
21:7.0.1.1.2.1.1.7	SECTION 601.8	601.8 Publication of revocation.
21:7.0.1.1.2.1.1.8	SECTION 601.9	601.9 Licenses; reissuance.
21:7.0.1.1.2.2	SUBPART B	Subpart B [Reserved]
21:7.0.1.1.2.3	SUBPART C	Subpart C - Biologics Licensing
21:7.0.1.1.2.3.1.1	SECTION 601.12	601.12 Changes to an approved application.
21:7.0.1.1.2.3.1.2	SECTION 601.14	601.14 Regulatory submissions in electronic format.
21:7.0.1.1.2.3.1.3	SECTION 601.15	601.15 Foreign establishments and products: samples for each importation.
21:7.0.1.1.2.3.1.4	SECTION 601.20	601.20 Biologics licenses; issuance and conditions.
21:7.0.1.1.2.3.1.5	SECTION 601.21	601.21 Products under development.
21:7.0.1.1.2.3.1.6	SECTION 601.22	601.22 Products in short supply; initial manufacturing at other than licensed location.
21:7.0.1.1.2.3.1.7	SECTION 601.27	601.27 Pediatric studies.
21:7.0.1.1.2.3.1.8	SECTION 601.28	601.28 Annual reports of postmarketing pediatric studies.
21:7.0.1.1.2.3.1.9	SECTION 601.29	601.29 Guidance documents.
21:7.0.1.1.2.4	SUBPART D	Subpart D - Diagnostic Radiopharmaceuticals
21:7.0.1.1.2.4.1.1	SECTION 601.30	601.30 Scope.
21:7.0.1.1.2.4.1.2	SECTION 601.31	601.31 Definition.
21:7.0.1.1.2.4.1.3	SECTION 601.32	601.32 General factors relevant to safety and effectiveness.
21:7.0.1.1.2.4.1.4	SECTION 601.33	601.33 Indications.
21:7.0.1.1.2.4.1.5	SECTION 601.34	601.34 Evaluation of effectiveness.
21:7.0.1.1.2.4.1.6	SECTION 601.35	601.35 Evaluation of safety.
21:7.0.1.1.2.5	SUBPART E	Subpart E - Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
21:7.0.1.1.2.5.1.1	SECTION 601.40	601.40 Scope.
21:7.0.1.1.2.5.1.2	SECTION 601.41	601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
21:7.0.1.1.2.5.1.3	SECTION 601.42	601.42 Approval with restrictions to assure safe use.
21:7.0.1.1.2.5.1.4	SECTION 601.43	601.43 Withdrawal procedures.
21:7.0.1.1.2.5.1.5	SECTION 601.44	601.44 Postmarketing safety reporting.
21:7.0.1.1.2.5.1.6	SECTION 601.45	601.45 Promotional materials.
21:7.0.1.1.2.5.1.7	SECTION 601.46	601.46 Termination of requirements.
21:7.0.1.1.2.6	SUBPART F	Subpart F - Confidentiality of Information
21:7.0.1.1.2.6.1.1	SECTION 601.50	601.50 Confidentiality of data and information in an investigational new drug notice for a biological product.
21:7.0.1.1.2.6.1.2	SECTION 601.51	601.51 Confidentiality of data and information in applications for biologics licenses.
21:7.0.1.1.2.7	SUBPART G	Subpart G - Postmarketing Studies
21:7.0.1.1.2.7.1.1	SECTION 601.70	601.70 Annual progress reports of postmarketing studies.
21:7.0.1.1.2.8	SUBPART H	Subpart H - Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible
21:7.0.1.1.2.8.1.1	SECTION 601.90	601.90 Scope.
21:7.0.1.1.2.8.1.2	SECTION 601.91	601.91 Approval based on evidence of effectiveness from studies in animals.
21:7.0.1.1.2.8.1.3	SECTION 601.92	601.92 Withdrawal procedures.
21:7.0.1.1.2.8.1.4	SECTION 601.93	601.93 Postmarketing safety reporting.
21:7.0.1.1.2.8.1.5	SECTION 601.94	601.94 Promotional materials.
21:7.0.1.1.2.8.1.6	SECTION 601.95	601.95 Termination of requirements.

---