FDA's Strategic priorities for 2011-2015 in response to the Public Health Challenges of the 21st Century

  • Date: October 15, 2010
  • Source:
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Purpose of the Guidance
The purpose of preparing the document is to outline FDA’s strategic intentions and plans for the next five years (2011 – 2015). This document is intended to communicate the Commissioner’s key priorities, including cross‐cutting strategic priorities, program‐specific strategic goals, and long‐term objectives. These goals and objectives provide the vehicle for focusing agency efforts to achieve FDA’s public health mission and to fulfill our role in supporting the larger mission and strategic goals of HHS.
FDA Principles
Principles of FDA and HHS are science‐based decision making, innovation/ collaboration, transparency, and accountability. Along with these four principles, “Manage for Operational Excellence and Accountability” is another significant principle which FDA is following while developing this strategic document. These principles govern deliberations, decision making, and actions and provide the framework for interactions within FDA, with the public, and with other FDA stakeholders.
Objectives of the Guidance
  • Advance Food Safety and Nutrition
    • Ensure the Safety of the Food Supply from Farm to Table
    • Promote Healthy Dietary Practices and Nutrition
  • Promote Public Health by Advancing the Safety and Effectiveness of Medical Products
    • Advance Human Drug Safety and Effectiveness
    • Advance Biologics Safety and Effectiveness
    • Advance Medical Device Safety and Effectiveness
    •  Advance Animal Drug Safety and Effectiveness
  • Establish an Effective Tobacco Regulation, Prevention, and Control Program
  • Manage for Organizational Excellence and Accountability
 Implementation of the strategic priority will be a tiered planning framework which will start from agency level where cross‐program work groups will develop plans— such as the Strategic Plan for Risk Communication, Strategic Human Capital Plan, and the Information Technology Strategic Plan—to address cross‐cutting strategies. In the program level, each Center and the Office of Regulatory Affairs will develop plans that reflect program‐specific strategies and metrics for monitoring progress toward achieving strategic objectives. The annual budget formulation and implementation planning will be done by the senior leadership of FDA.
Read the Complete Draft Document, by downloading the file below

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