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FDA 'transparency' task force to tackle recalls, safety issues

This article was originally published in The Silver Sheet

Executive Summary

FDA has formed a task force to identify more effective ways to explain controversial agency decisions to the public, including those relating to device recalls, enforcement actions, product approvals and other agency operations. Principal Deputy Commissioner Joshua Sharfstein will lead the task force of senior FDA officials, which will solicit recommendations from inside and outside the agency on how it can make "useful and understandable information on its activities and decisions" more readily available. The group has six months to come up with recommendations to FDA Commissioner Margaret Hamburg. FDA has been criticized by safety advocates and members of Congress for failing to warn the public in time about safety issues, and in some cases for approving products without sufficient consideration of safety and effectiveness. The committee will convene two public meetings this year to collect stakeholder input on the transparency goal. The first gathering takes place June 24 in Washington, D.C., with the second meeting date yet to be determined
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