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Program Assessment


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Food and Drug Administration

The Food and Drug Administration regulates the safety and effectiveness of human and animal drugs; medical devices, vaccines, and animal feeds; and the safety of food. It accomplishes these tasks through premarket review of new products and continued safety surveillance of products already available to consumers.


What This Rating Means

Moderately Effective

In general, a program rated Moderately Effective has set ambitious goals and is well-managed. Moderately Effective programs likely need to improve their efficiency or address other problems in the programs' design or management in order to achieve better results.
  • This program has a strong strategic planning process driven by its Strategic Planning Council. Top-level leaders meet monthly to address strategic issues; reviewing and updating the agency's strategic plan; ensuring alignment of its annual performance budget with long-term plans and that long-term technology investment strategies support FDA's overall strategic and long-term goals.
  • It exceeds many of its annual performance goals for inspections and pre-market review. In 2004, it completed review and action on 96% of priority New Drug Applications and Biologics Licensing Applications within 6 months. It also completed review and action on 98% of Pre-Market Approval application supplements for medical devices within 180 days, despite a 30% increase in applications.
  • The program developed a set of long term outcome goals. With these goals, FDA reduced its average time to marketing approval for safe and effective new drugs, biologics, and medical devices, (a reduction of 30 days from 2000 to 2003) and increased its capacity to effectively analyze food samples for biological, chemical and radiological threat agents in the event of a terrorist attack.

Improvement Plan

About Improvement Plans

We are taking the following actions to improve the performance of the program:

  • Developing a new efficiency measure to measure improvements in cost effectiveness.
  • Updating and reporting on the long term outcome goals that will improve the health and well-being of the American Public.

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