GAO Criticizes FDA’s Approach to Regulatory Science

June 21, 2016

The U.S. Government Accountability Office faulted the FDA’s approach to regulatory science and its strategic management plan in a report issued last week critical of the agency.

According to the GAO report on FDA’s regulatory efforts, the FDA’s 2011 and 2013 strategic planning documents for regulatory science efforts lack measureable goals for evaluating its progress, such as specific targets and time frames necessary to assess progress.

The report notes that the agency’s 2013 planning documents — which proposed measuring progress by describing product-specific advisory committees and staff training opportunities related to the priority areas of regulatory science — lacked objective criteria for gauging the effectiveness of these efforts.

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