FDA ‘Strategic Priorities 2011 – 2015’

The FDA released its strategic plan for 2011 to 2015 with an emphasis on international food safety programs. The link and the text of the release are below:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm252106.htm

The U.S. Food and Drug Administration today released the final version of a strategic priorities document outlining the goals that will guide the agency and its 12,000 employees through 2015.

“It’s no secret that the FDA’s responsibilities have increased significantly over the past several years,” said FDA Commissioner Margaret A. Hamburg, M.D. “We must continue to build a stronger, more effective agency and, as this document outlines, do so in several specific ways.” Titled “Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century,” the 50-page document provides a vision of the FDA that includes:

  • a modernized 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
  • an integrated global food safety system focused on prevention and improved nutrition
  • expanded efforts to meet the needs of special populations.

“Today, it is clear that the FDA’s job is fundamentally different – and far more complex than it was even a few years ago,” Hamburg said. “We will address these challenges and aim to fulfill our mission by embracing innovation and actively pursuing partnerships with federal, state, and local agencies, international authorities, academia, non-government organizations, and the private sector.”

The FDA commissioner added that she would continue to act as an advocate for advancing the field of regulatory science and innovation, one of five cross-cutting areas that serve as strategic priorities at the agency over the next five years. “Science underlies everything we do,” Hamburg said. “To serve the public health, we must have the capacity to effectively oversee the translation of breakthrough discoveries in science into innovative, safe, and effective products and life-saving therapies.” Senior staff from the FDA’s seven product and research centers and two major offices contributed to the document.

A Federal Register notice that invited public comment in October 2010 generated more than 200 comments and the final document includes that input. The FDA’s “Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century,” contains four sections:

  1. Introduction
  2. Cross-Cutting Strategic Priorities
  3. Strategic Goals and Long-Term Objectives
  4. Implementation

 View PDF of full document

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