The information on this page is current as of Mar 22, 2024.
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
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.
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.
This website has been translated to Spanish from English, and is updated often. It is possible that some links will connect you to content only available in English or some of the words on the page will appear in English until translation has been completed (usually within 24 hours). We appreciate your patience with the translation process. In the case of any discrepancy in meaning, the English version is considered official. Thank you for visiting esp.fda.gov/tabaco.
Page Last Updated: 03/22/2024