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FDA warning letter responses

This article was originally published in The Rose Sheet

Executive Summary

Business responses to agency warning letters will be posted on FDA's Web site during a six-month pilot program, agency announces in a Federal Register notice scheduled to be published June 23. The program, which will begin 90 days following publication of the notice, is part of FDA's ongoing effort to inform the public about agency activities, agency adds. Responses only will be posted if recipient requests the posting and submits their response in appropriate electronic format. Following testing period, FDA will decide whether program should be permanent...



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