> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Needs Regulatory Science Goals: GAO
- URL: https://www.fdaweb.com/fda-needs-regulatory-science-goals-gao/
- Published: 2016-06-15T12:00:00.000Z
- Updated: 2026-09-14T21:09:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135946

The Government Accountability Office (GAO) says that FDA lacks measurable goals with which to assess its progress in advancing regulatory science. “The agency issued strategic planning documents in 2011 and 2013 to guide its regulatory science efforts and identify priority areas for conducting work,” the GAO says in a new [report](http://www.gao.gov/products/GAO-16-432?ref=fdaweb.com), “but these documents do not specify the time frames necessary for the agency to measure progress overall or within each of the eight priority areas related to medical products.”

GAO says it was asked to examine the agency’s progress on its regulatory science efforts related to medical products. Its report evaluates FDA’s strategic planning efforts to address its regulatory science priorities; describes agency funding targeted at regulatory science projects; and describes the achievements of selected FDA regulatory science projects.

“While FDA cited examples of its achievements in regulatory science in a 2015 report,” the document says, “FDA cannot assess how those achievements constitute progress towards its goals. In addition, FDA lacks information about how funding targeted at regulatory science is distributed across the priority areas. Decisions to award these funds are made by individual FDA Centers and offices, which generally did not collect information on the associated priority areas of funding projects. Rather, FDA retrospectively identified these areas for the purpose of GAO’s review. The lack of consistent information limits FDA’s ability to examine obligations across, or progress within, specific priority areas.”

GAO recommended that FDA **(1)** develop and document measurable goals, including targets and time frames; and **(2)** systematically track funding across its regulatory science priority areas. FDA agreed with the recommendations.