An index is provided of relevant sections of Title 21, Code of Federal Regulations which cover the safety surveillance of drugs which are required of manufacturers in the United States. A relevant guideline and a guidance manual prepared by the Food and Drug Administration are also indexed.
Title 21 Code of Federal Regulations. 20.63, 310.305, 312.32, 314.50, 314.80. Washington, DC: U.S. Government Printing Office; 1995.
2.
Guideline for Postmarketing Reporting of Adverse Drug Experiences [Docket No. 85D-0249]. Washington, DC: Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; March 1992.
3.
Chapter 53—Postmarketing Surveillance and Epidemiology. In: Compliance Program Guidance Manual, Program 7353.001. Washington, DC: Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; September 30, 1995.
4.
Part VII Department of Health and Human Services. Food and Drug Administration, 21 CFR 201, et al. Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products; Proposed Rule. Federal Register. October 27, 1994; 59(207):54046–64.
5.
International Conference on Harmonisation; Guide-Une on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; Availability. Federal Register. March 1, 1995;60(40): 11284–7.
