Health Risk Assessment Practices in the U.S. Food and Drug Administration

• Published in: Regulatory toxicology and pharmacology Vol. 26; no. 3; pp. 307 - 321
• Main Authors: Gaylor, D.W., Axelrad, J.A., Brown, R.P., Cavagnaro, J.A., Cyr, W.H., Hulebak, K.L., Lorentzen, R.J., Miller, M.A., Mulligan, L.T., Schwetz, B.A.
• Format: Journal Article
• Language: English
• Published: San Diego, CA Elsevier Inc 01.12.1997; Elsevier
• Subjects: Animals; Biological and medical sciences; Health Status Indicators; Humans; Medical sciences; National institutions; Organizations and institutions for the application of policies; Public health. Hygiene; Public health. Hygiene-occupational medicine; Risk Assessment; United States; United States Food and Drug Administration; United States; North America; America; Human; Drug; Evaluation; Radiation; Risk; Biology; Review; Management; Regulatory institution; Investigation method; Professional practice; Safety; Food and Drug Administration; Public health; Food
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1006/rtph.1997.1156

The U.S. Food and Drug Administration (FDA) regulates a wide variety of consumer products. Safety issues involve chemical and microbial contaminants in food, biologics, 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.