Regulatory News In Brief
This article was originally published in The Gray Sheet
Transparency proposal feedback: Comments are due July 20 on information FDA is considering making available to the public, the agency noted on its "transparency blog" last week. The agency released 21 draft 1proposals May 19, including ideas such as allowing FDA to publicly explain why it rejects certain product applications, share information about FDA inspections or common inspection problems, and give doctors and patients summaries of safety and effectiveness data from medical product applications (2"The Gray Sheet" May 24, 2010)
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The FDA device center's upcoming proposals for reforming its pre-market policies will directly address widespread industry concern that reviews are increasingly unpredictable and opaque, CDRH Director Jeff Shuren told an industry audience last week
FDA may publicly disclose more information on specific devices prior to marketing approval under a May 19 proposal to increase transparency
Not surprisingly, questions and fears surrounding 510(k) reform dominated a "town hall" forum held by CDRH Director Jeffrey Shuren and other center managers in Minneapolis May 18