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FDA NEW DRUG REVIEW CARCINOGENICITY ASSESSMENTS

Executive Summary

FDA NEW DRUG REVIEW CARCINOGENICITY ASSESSMENTS will be referred routinely to a new internal advisory group within the agency, the Carcinogenicity Assessment Committee (CAC). The committee was formed at the beginning of this year to aid the Center for Drug Evaluation's scientific review divisions in assuring consistency in evaluations of cancer studies. In addition to standardly advising on the carcinogenicity studies portion of new drug applications, the committee will examine other carcinogenicity issues as requested by the agency. The committee reviews carcinogenicity study results, design and execution, then issues an advisory opinion to the appropriate review group within FDA. The group is chaired by Judi Weissinger, PhD, assistant director for pharmacology/toxicology, Office of Drug Evaluation II. The regular members of the panel include the supervisory pharmacologists of the new drug review divisions and the head of the statistical animal review branch. The statistical and pharmacology/toxicology reviewers on the drug being evaluated become temporary members. The committee will also call in special advisors on an ad hoc basis, including office directors and deputy directors, veterinary pathologists from the National Toxicology Program, and members of a counterpart carcinogenicity assessment group already in existence at FDA's Center for Food Safety and Applied Nutrition. One near-term project for the CAC is the ongoing debate on the carcinogenic potential of the popular anti-acne drug benzoyl peroxide ("The Pink Sheet" July 2, p. 9), at the request of the Office of OTC Drug Evaluation.

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