Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
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)