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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
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Date created: July 23, 2007 |
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