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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

FDA transparency with industry: FDA is collecting information on ways it can improve transparency with regulated industries, the third phase of its ongoing transparency initiative. FDA says it held three listening sessions with members of regulated industry on Jan. 21, 27 and 28 and will publish transcripts of those sessions on the dockets. The agency seeks public comment on issues raised during the meetings and on how it can improve regulatory training and education for industry; guidance development; channels of communication with industry routinely and during crises; useful and timely answers to industry questions; and communications with sponsors during application reviews. Comments are due April 12

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