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Title 21 - Title 21
Part 601 - LICENSING
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BIOLOGICS - LICENSING
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39 sections
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§601.12 - Changes to an approved application.
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§601.14 - Regulatory submissions in electronic format.
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§601.15 - Foreign establishments and products: samples for each importation.
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§601.2 - Applications for biologics licenses; procedures for filing.
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§601.20 - Biologics licenses; issuance and conditions.
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§601.21 - Products under development.
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§601.22 - Products in short supply; initial manufacturing at other than licensed location.
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§601.27 - Pediatric studies.
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§601.28 - Annual reports of postmarketing pediatric studies.
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§601.29 - Guidance documents.
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§601.3 - Complete response letter to the applicant.
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§601.30 - Scope.
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§601.31 - Definition.
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§601.32 - General factors relevant to safety and effectiveness.
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§601.33 - Indications.
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§601.34 - Evaluation of effectiveness.
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§601.35 - Evaluation of safety.
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§601.4 - Issuance and denial of license.
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§601.40 - Scope.
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§601.41 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
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§601.42 - Approval with restrictions to assure safe use.
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§601.43 - Withdrawal procedures.
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§601.44 - Postmarketing safety reporting.
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§601.45 - Promotional materials.
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§601.46 - Termination of requirements.
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§601.5 - Revocation of license.
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§601.50 - Confidentiality of data and information in an investigational new drug notice for a biological product.
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§601.51 - Confidentiality of data and information in applications for biologics licenses.
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§601.6 - Suspension of license.
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§601.7 - Procedure for hearings.
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§601.70 - Annual progress reports of postmarketing studies.
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§601.8 - Publication of revocation.
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§601.9 - Licenses; reissuance.
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§601.90 - Scope.
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§601.91 - Approval based on evidence of effectiveness from studies in animals.
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§601.92 - Withdrawal procedures.
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§601.93 - Postmarketing safety reporting.
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§601.94 - Promotional materials.
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§601.95 - Termination of requirements.
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