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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADM...
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PART 601—LICENSING
PART 601—LICENSING
§ 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.