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In Brief: CFSAN/CDER meetings

This article was originally published in The Tan Sheet

Executive Summary

CFSAN/CDER meetings: Center for Food Safety & Applied Nutrition and Center for Drug Evaluation & Research have met "extensively" over the past several weeks to resolve differences in the way the two handle issues such as product claims "so that everyone is speaking from the same page," CFSAN Office of Food Labeling Director Edward Scarbrough, PhD, said during Q&A at the Food & Drug Law Institute's Food Regulatory Update '97, held June 2-3 in Washington, D.C. "There is not this huge chasm between the centers...however, that perception exists now, and it exists to the extent" that it concerned Deputy Commissioner William Schultz, Scarbrough said. "There is a big concern that we all stay on the same page within the agency," he noted. The audience had been discussing the issuance of warning letters by CDER versus courtesy letters by CFSAN. Most recently, the issue of claims perception by different FDA centers arose with Pharmanex' supplement Cholestin, which claims to lower cholesterol ("The Tan Sheet" April 14, pp. 1-4)...
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