Laboratory Information:
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Life Sciences Building 64 - Rm 2076
Silver Spring, MD 20993
Website: http://www.fda.gov/cder/
Technology Transfer Website: http://www.fda.gov/AboutFDA/business/ucm119486.htm
Agency/Department: Dept. of Health and Human Services
Region: Mid-Atlantic
FLC Laboratory Representative:
Dr. Joseph Hanig
Phone: 301-796-0079
Fax: 301-796-9818
Email: joseph.hanig.fda.hhs.gov
Background/History of the Laboratory:
The Center for Drug Evaluation and Research
(CDER), which assures that safe and effective drugs are available
to the American people, has gone through a functional and organizational metamorphosis since it began
as a one-
man operation to assess significant drug problems in the marketplace on the eve of
the 1906 Pure Food and
Drugs Act. In part, this change reflects the evolution of drug law and the chemotherapeutic revolution
over the 20th
century and the concomitant changes in responsibilities of the Food and Drug Administration. But the
change also
reflects external and internal decisions on how best to provide safe and effective drugs to patients.
Every branch of
government, as well as other interests affected by FDA's policies, have had a role in the way this agency
regulates
drugs.
Mission of the Laboratory:
The mission of FDA's Center for Drug Evaluation
and Research is to assure that safe and effective drugs are
available to the American people.
Technology Transfer Mechanisms:
- Cooperative Research and Development Agreements (CRADAs)
- Patents and Licensing
- Technical Assistance
Technology Areas of Expertise:
- Generic drug review
- New drug development and review
- Over-the-counter drug review
- Post drug approval process
