Improving Public Participation and Transparency at FDA with Earlier Availability of Advisory Committee Materials

Posted 15 July 2013 By Mitchell Berger, MPH, RAC

This article provides an overview of statutory and regulatory provisions, policies and FDA guidance documents governing the timing of release of materials for Advisory Committee meetings. This review suggests that Advisory Committee materials subject to public disclosure should be publicly released further in advance of the Advisory Committee meeting.

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Categories: US, FDA

Tags: Transparency, AdComm, Perspective, advisory committee, guidance

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