Code of Federal Regulations - Biologics Related
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year.
Title 21 of the CFR concerns Food and Drugs. The following Parts contain general and permanent rules pertaining to products under the purview of CBER.
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Includes general enforcement regulations, product jurisdiction, enforcement policy, hearings, protection of human subjects, financial disclosure by clinical investigators, institutional review boards, good laboratory practice for nonclinical laboratory studies
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Includes labeling, advertising, registration, medication guides, good manufacturing practices, product official and established names
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Includes combination drugs, new drugs, investigational new drug (IND) application, application for approval to market, orphan drugs, bioavailability and bioequivalence
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Includes information for biological products: general, licensing, good manufacturing practice for blood and blood components, establishment registration for manufacturers of blood and blood products, product standards, requirements for human blood and blood products
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Includes information for medical devices: general, labeling, reporting, in vitro diagnostic products, investigational device exemptions, premarket approval, postmarket surveillance, classification procedures
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Human Tissue Intended for Transplantation
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Human Cells, Tissues and Cellular and Tissue-Based Products
The Code of Federal Regulations (1996-2007) is available for browsing and/or searching via GPO Access.