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U.S. Department of Health and Human Services

About FDA

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Office of Testing and Research Mission

Federal Research Center
White Oak Office Building #22
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-1213 Fax: (301) 796-9859

Vincent L. Vilker, Ph.D., Director

The mission of the Office of Testing and Research is to:

  • Advance the scientific basis of regulatory policy
  • Assure that regulatory policy and decision making are based on the best available science
    • provide the laboratory science necessary for evaluation of safety, efficacy and quality of the U.S. drug supply
  • Provide laboratory leadership
    • provide the laboratory capability to empower completion of the goals of the critical path
    • facilitate introduction of new technology
    • Provide professional development and training opportunities to CDER reviewers

Activities related to the above mission include:

  • Developing new scientific methods and new regulatory testing paradigms to assure the identity, quality, safety, and effectiveness of human drug products
  • Providing scientific support for the development and application of regulatory policy and decision-making
  • Setting direction for drug quality surveillance activities for the Center, as required by regulations
  • Conducting and coordinating applied drug research that converts new scientific knowledge to regulatory applications
  • Providing scientific training for employees through the development and coordination of Staff College and related programs
  • Initiating and coordinating scientific workshops, and sponsoring cooperative training and educational programs