Food and Drug Administration risk assessment--process and toxicologic pathology.
A general outline of the risk assessment process at the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration based on the toxicologic evaluation of data is described. Examples of recent pathology evaluations are presented to illustrate primarily the pathology review process at the CFSAN. These examples include the review of data from rodent studies from proposed indirect food additives and data from dog studies submitted in support of an investigational new drug, a short-acting opioid, proposed as an anesthetic in humans.
Moch
R W
RW
Pathology Branch, U.S. Food and Drug Administration, Washington, D.C. 20204, USA.
Dua
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PN
Hines
F A
FA
D000818:Animals; D005503:Food Additives / Q000633:toxicity*; D006801:Humans; D010338:Pathology, Clinical / Q000331:legislation & jurisprudence* / Q000639:trends; D018570:Risk Assessment; D014116:Toxicology / Q000331:legislation & jurisprudence* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration
D005503:Food Additives