21 C.F.R. PART 601--LICENSING
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F--BIOLOGICS
PART 601--LICENSING
Subpart A--GENERAL PROVISIONS
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| Applications for biologics licenses; procedures for filing.
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| Issuance and denial of license.
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| Publication of revocation.
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Subpart B--[RESERVED]
Subpart C--BIOLOGICS LICENSING
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| Changes to an approved application.
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| Regulatory submissions in electronic format.
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| Foreign establishments and products: samples for each importation.
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| Biologics licenses; issuance and conditions.
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| Products under development.
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| Products in short supply; initial manufacturing at other than licensed location.
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| Review procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use.
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| Reclassification procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use.
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| Annual reports of postmarketing pediatric studies.
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Subpart D--DIAGNOSTIC RADIOPHARMACEUTICALS
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| General factors relevant to safety and effectiveness.
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| Evaluation of effectiveness.
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Subpart E--ACCELERATED APPROVAL OF BIOLOGICAL PRODUCTS FOR SERIOUS OR LIFE-THREATENING ILLNESSES
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| Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
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| Approval with restrictions to assure safe use.
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| Postmarketing safety reporting.
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| Termination of requirements.
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Subpart F--CONFIDENTIALITY OF INFORMATION
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| Confidentiality of data and information in an investigational new drug notice for a biological product.
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| Confidentiality of data and information in applications for biologics licenses.
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Subpart G--POSTMARKETING STUDIES
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| Annual progress reports of postmarketing studies.
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Subpart H--APPROVAL OF BIOLOGICAL PRODUCTS WHEN HUMAN EFFICACY STUDIES ARE NOT ETHICAL OR FEASIBLE
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| Approval based on evidence of effectiveness from studies in animals.
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| Postmarketing safety reporting.
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| Termination of requirements.
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