Draft guidance proposals from industry allowed under FDA "good guidance practices" policy.
This article was originally published in The Gray Sheet
Executive Summary
DRAFT GUIDANCE PROPOSALS BY INDUSTRY TO FDA PERMITTED under the agency's "good guidance practices" policy published in Feb. 27 Federal Register. The GGP includes a "guidance proposal policy" whereby the public will have "an opportunity to propose topics for new or revised guidance or to propose draft guidance documents." FDA says it is allowing members of the public to propose guidance to encourage input during the guidance development and revision process.
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