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One in a Series of Information Sheets from FDA
The FDA's Center for Drug Evaluation and Research (CDER) promotes and protects the health of Americans by assuring that all prescription and over-the-counter drugs are safe and effective. CDER evaluates all new drugs before they are sold, and serves as a consumer watchdog for the more than 10,000 drugs on the market to be sure they continue to meet the highest standards. The center routinely monitors TV, radio, and print drug ads to ensure they are truthful and balanced. CDER also plays a critical role in providing health professionals and consumers information to use drugs appropriately and safely.
In 2002, the center focused on five strategic areas:
For more information, please go to the CDER Web site at www.fda.gov/cder, or call (888) INFO-FDA (888-463-6332), and follow the prompts for human drugs.
In 2002, CDER approved 78 new drugs, 17 of which were never before marketed in the United States. Eleven of the new drugs received priority status in recognition of their special importance for the public health. Thirteen of the newly approved drugs were authorized for over-the-counter sale without a prescription. The center also approved 321 generic versions of already-marketed drugs. More details about CDER's accomplishments in 2002 can be found in the CDER Report to the Nation: 2002 at ww.fda.gov/cder/reports/rtn/2002/rtn2002.htm.
Publication No. FS 01-3
Revised: August 2003