An Index of United States Federal Regulations and Guidelines Which Cover Clinical Safety Surveillance of Biological Products

Abstract

An index is provided covering relevant sections of Title 21, Code of Federal Regulations governing the safety surveillance of biological products which are required of manufacturers in the United States. This index also covers relevant guidelines published by the United States Food and Drug Administration.

Keywords

United States regulations Biological products safety Food and Drug Administration

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References

Title 21 Code of Federal Regulations. 600.80. Washington, DC: U.S. Government Printing Office; 1995.

Guideline for Adverse Experience Reporting for Licensed Biological Products. Washington, DC: Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; October 15, 1993.