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Mechanisms for industry input on FDA guidance agenda suggested in comments.

This article was originally published in The Gray Sheet

Executive Summary

GUIDANCE DOCUMENT "CALENDAR" COULD PROVIDE OPPORTUNITY FOR INDUSTRY PROPOSALS for FDA guidance documents, in addition to listing the agency's guidance development plans, Steris says in recent comments on FDA's good guidance practices proposal ("The Gray Sheet" March 11, I&W-3). The calendar "would list all planned guidance document activities, including all opportunities for written and oral comments, and would allow members of the public to propose guidance document topics," the sterilizer company suggests. FDA or an industry committee "may need to loosely filter" the proposals "to avoid an explosion of meritless calendar listings," Steris adds.

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