Document Detail

Health risk assessment practices in the U.S. Food and Drug Administration.
MedLine Citation:
PMID:  9441921     Owner:  NLM     Status:  MEDLINE    
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.
D W Gaylor; J A Axelrad; R P Brown; J A Cavagnaro; W H Cyr; K L Hulebak; R J Lorentzen; M A Miller; L T Mulligan; B A Schwetz
Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Regulatory toxicology and pharmacology : RTP     Volume:  26     ISSN:  0273-2300     ISO Abbreviation:  Regul. Toxicol. Pharmacol.     Publication Date:  1997 Dec 
Date Detail:
Created Date:  1998-03-05     Completed Date:  1998-03-05     Revised Date:  2005-11-16    
Medline Journal Info:
Nlm Unique ID:  8214983     Medline TA:  Regul Toxicol Pharmacol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  307-21     Citation Subset:  IM    
National Center for Toxicological Research, Rockville, MD, USA.
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MeSH Terms
Health Status Indicators*
Risk Assessment*
United States
United States Food and Drug Administration*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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