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

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Subpart A--GENERAL PROVISIONS

�601.2
Applications for biologics licenses; procedures for filing.
�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.
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Subpart B--[RESERVED]

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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.
�601.25
Review procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use.
�601.26
Reclassification procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use.
�601.27
Pediatric studies.
�601.28
Annual reports of postmarketing pediatric studies.
�601.29
Guidance documents.
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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.
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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.
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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.
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Subpart G--POSTMARKETING STUDIES

�601.70
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

�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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