21 CFR Part 601
PART 601—LICENSING
- PART 601—LICENSING
- 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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