Health risk assessment practices in the U.S. Food and Drug Administration

Regulatory Toxicology and Pharmacology : RTP
D W GaylorB A Schwetz

Abstract

The U.S. Food and Drug Administration (FDA) regulates a wide variety of consumer products. Safety issues involve chemical and microbial contaminants in food, biologies, and medical devices; side effects from prescription and nonprescription drugs; residues of animal drugs in food; and radiation from electronic devices. Because of this wide diversity, the legal standards, rules, and policies governing the regulation of these products differ considerably. Hence, risk assessment and risk management practices within the FDA are of necessity quite diverse. This paper presents a summary of risk assessment practices at each of the product centers of the FDA (Center for Food Safety and Applied Nutrition, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Veterinary Medicine) and of the development of risk assessment procedures at the National Center for Toxicological Research.

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Citations

Dec 18, 2001·Environmental Health Perspectives·H Tryphonas
Jun 13, 2006·American Journal of Infection Control·Elaine Larson, Allison E Aiello
Aug 10, 2015·Regulatory Toxicology and Pharmacology : RTP·Kara E Woeller, Anne E Hochwalt
Jun 7, 2005·Regulatory Toxicology and Pharmacology : RTP·Allan B BaileyMichelle L Twaroski
Feb 7, 2007·Psychopharmacology·Lacramioara Spetie, L Eugene Arnold
Jun 24, 2018·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Winson Y CheungKathryn Lasch
May 1, 2001·Current Protocols in Toxicology·W Slikker
Jul 7, 2012·Environmental Science and Pollution Research International·A DvorskáM Kubal

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