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FDA releases strategic priorities

The US Food and Drug Administration (FDA) has released a 50-page document outlining its strategic priorities for the next five years
The US Food and Drug Administration (FDA) has released a 50-page document outlining its strategic priorities for the next five years. Titled "Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century," the document focuses largely on the need for "a modernised field of regulatory science that draws on innovations in science and technology to help ensure the safety and effectiveness of medical products throughout their life cycles."

"Over the next five years, FDA will create and implement a strategic plan for expanding and modernising the field of regulatory science within the agency," the document states. "This plan will complement each of FDA's programme specific strategic plans, which focus on advancing scientific approaches and tools critical for FDA to translate science into regulation and public health. In addition, FDA will develop an innovation strategy that focuses on its role in facilitating the development of new biomedical products and emerging technologies. At the same time, we will work to strengthen science as a whole within FDA."

Other priorities outlined in the plan include an integrated global food safety system focused on prevention and improved nutrition; expanding efforts to meet the needs of special populations; strengthening the safety of the global supply chain; stepping up compliance and enforcement activities; and advancing medical countermeasures and preparedness for emergencies.

The final document was formulated by senior staff from the FDA's seven product and research centres and two major offices. The report takes into account more than 200 public comments that were submitted to the federal agency after it released a draft version of the list of priorities. 

The FDA said it will use the priorities and goals laid out in the final document to improve its operating infrastructure, modernise its regulatory processes and strengthen its workforce. "The FDA must have the capacity to effectively oversee the translation of breakthrough discoveries in science into innovative, safe, and effective products and life-saving therapies," FDA Commissioner Margaret A Hamburg said in a blog posting. "This document sets forth our priorities for achieving that goal."

21st April 2011

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