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FDA
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Within FDA, the Center for Drug Evaluation and Research (CDER) promotes, protects, and enhances the health of the public through the drug development and evaluation process. CDER approves drugs for marketing that are effective for their labeled indications, provide benefits that outweigh risks, are of high quality, and have clear, complete directions for use. CDER also facilitates early access to promising experimental drugs for serious illnesses, promotes innovation, ensures the safety of patients in drug studies, and ensures that product quality and safety are maintained after marketing.
CDER's International Activities
Coordinating Committee (IACC), chaired by the Center Director, was established
to lead the Center's participation in international initiatives and to coordinate
and discuss these activities.
The Division of Drug Information acts as the Center's main drug information contact and publication source. For example, CDER maintains a list of guidelines that apply to the Center's regulations; these guidelines state procedures or practices that may be useful but that are not legally required. A list of available guidelines and information on how to obtain copies, as well as a complete CDER organization chart or list of publications, are available from:
Telephone: 301-827-4573
FAX: 301-827-4577
Internet: druginfo@cder.fda.gov.
The Associate Director for International Affairs is the point of contact for drug approval harmonization efforts:
Telephone: 301-594-2847
FAX: 301-827-3698
Certificates for Pharmaceutical
Products
may be obtained
from the Division of Labeling and Nonprescription Drug Compliance:
Telephone: 301-594-3150
FAX: 301-594-0165.
Many of CDER's guidelines are available electronically.
For drug approval information, access FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, 19th Edition (commonly called the Orange Book). If you prefer, you can subscribe to the Orange Book at a cost of $101.00 per year ($126.25 international) by writing to the Superintendent of Documents, US Government Printing Office, PO Box 371954, Pittsburgh, PA 15250-7954; FAX: 202-512- 2250.
CDER's FAX on Demand - For same-day access to a wealth of CDER information, call 1- 800-342-2722 or 301-827-0577. You can press "1" to request an index of available documents or press "2" to have a specific document FAXed to you.
Other Agencies - The Drug Enforcement Administration (DEA) is the United States agency primarily responsible for enforcement of the provisions of the Controlled Substances Act as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances (as well as those that appear in or are destined for illicit traffic in the United States). It is also the lead agency for the development of overall Federal drug enforcement strategy, programs, planning, and evaluation. Its Public Affairs Office may be reached at 202-307-7977.
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