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Transparency comments sought

This article was originally published in The Tan Sheet

Executive Summary

FDA seeks comments on how to improve the agency's transparency to regulated firms, based on input received during Transparency Task Force meetings in January with food, drug and medical device industry representatives. Transcripts from those sessions are accessible at 1www.regulations.gov and on the task force's Web site, 2www.fda.gov/Transparency, according to a March 12 release. FDA is particularly interested in comments on how to make improvements in training and education for regulated industry about FDA's regulatory process in general or about specific new requirements; the guidance development process; maintaining open channels of communication with industry routinely and during crises; providing useful and timely answers to industry questions about specific regulatory issues; and communicating with sponsors during review of applications. Comments are due by April 12

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