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FEDERAL · 21 CFR

Part 601 — Licensing

39 sections · Title 21: Food and Drugs

§ 601.2Applications for biologics licenses; procedures for filing.
§ 601.3Complete response letter to the applicant.
§ 601.4Issuance and denial of license.
§ 601.5Revocation of license.
§ 601.6Suspension of license.
§ 601.7Procedure for hearings.
§ 601.8Publication of revocation.
§ 601.9Licenses; reissuance.
§ 601.12Changes to an approved application.
§ 601.14Regulatory submissions in electronic format.
§ 601.15Foreign establishments and products: samples for each importation.
§ 601.20Biologics licenses; issuance and conditions.
§ 601.21Products under development.
§ 601.22Products in short supply; initial manufacturing at other than licensed location.
§ 601.27Pediatric studies.
§ 601.28Annual reports of postmarketing pediatric studies.
§ 601.29Guidance documents.
§ 601.30Scope.
§ 601.31Definition.
§ 601.32General factors relevant to safety and effectiveness.
§ 601.33Indications.
§ 601.34Evaluation of effectiveness.
§ 601.35Evaluation of safety.
§ 601.40Scope.
§ 601.41Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
§ 601.42Approval with restrictions to assure safe use.
§ 601.43Withdrawal procedures.
§ 601.44Postmarketing safety reporting.
§ 601.45Promotional materials.
§ 601.46Termination of requirements.
§ 601.50Confidentiality of data and information in an investigational new drug notice for a biological product.
§ 601.51Confidentiality of data and information in applications for biologics licenses.
§ 601.70Annual progress reports of postmarketing studies.
§ 601.90Scope.
§ 601.91Approval based on evidence of effectiveness from studies in animals.
§ 601.92Withdrawal procedures.
§ 601.93Postmarketing safety reporting.
§ 601.94Promotional materials.
§ 601.95Termination of requirements.