Tuesday, July 8, 2008

Role of FDA's Drug Information Centers

From American Journal of Health-System Pharmacy By: LCDR Kavita C. Dada, Pharm.D., USPHS; CDR Mary E. Kremzner, Pharm.D., USPHS; Sanjeev K. Bhanot, Pharm.D.; Renu Lal, Pharm.D.

Currently, two DICs are funded by the Food and Drug Administration (FDA): one in the Center for Biologics Evaluation and Research (CBER) and the other in the Center for Drug Evaluation and Research (CDER). Each DIC provides product information and regulatory guidance. The scope and breadth of FDA's mission present unique challenges to these DICs. Representing a large federal agency, these DICs serve a broader range of constituents than do DICs in hospitals, universities, and the pharmaceutical industry. In essence, they serve as FDA's liaison to the public.

Inquiries come from a broad range of sources, including consumers, patients, health care professionals, insurance companies, regulated industries (e.g., manufacturers), academia, law enforcement, FDA itself and other government agencies (nationally and internationally), investment brokers, attorneys, and others.

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