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How to Obtain Information About Prescription and Over-the-Counter Drugs
The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is a knowledge warehouse.
Do you want to know about potential drug-drug interactions, or the possibility of side effects? Do you have questions about the effectiveness of the latest baldness cure? If you are not even sure what questions to ask your health care provider or if you just wonder what fluoride really does for the teeth, CDER's Division of Drug Information can provide you with answers to these and hundreds of other questions that you may have about drugs.
Thousands of people call or write the FDA each year for information about drugs regulated by CDER. From aspirin to cancer treatments, CDER ensures that the benefits of drug products outweigh the known risks. The center has oversight responsibilities for human prescription, overthecounter, and generic drugs. This responsibility includes products that many consumers usually do not consider to be drugs, such as fluoride toothpaste, sunscreens, and dandruff shampoos.
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Located in the FDA's agency headquarters, the Division of Drug Information is the focal point for inquiries by pharmacists, doctors, nurses, pharmaceutical and insurance companies, federal agencies, consumers, and other constituencies.
Over the years, the division has answered an average of 4,000 telephone calls, 600 letters, and 2,800 e-mails per month. Staffed with pharmacists and other health care professionals experienced with drugrelated topics, the division's consumer safety officers (CSOs) consult with all areas of the FDA to get the most current information necessary to answer often detailed and complicated questions.
The staff services include:
responses to questions from health care professionals and consumers
"Approval" and "Hot Topic" information
providing overviews of center responsibilities to visiting foreign government officials
regulatory guidance to the pharmaceutical industry
liaison with CDER's divisions and compliance office to identify and resolve issues of drug availability.
In addition, the team is the storehouse for all CDER publications, Federal Register notices, drug product inserts, consumer articles, recall notices, and other drugrelated information.
As a follow-up to speaking with a health care professional, a CSO can usually give callers additional information. In addition, CSOs can help the caller navigate the CDER Web site or send articles, brochures, press releases, federal regulations, fact sheets, and other publications.
By law, FDA employees cannot release confidential information about unapproved drugs or clinical trials. Consumers should obtain this information from physicians, private/nonprofit organizations, or pharmaceutical companies.
How to Obtain Information
To obtain information or ask specific questions about your condition, prescription, and over-the-counter drugs, or related topics, you should consult a health care professional.
If you need more information, checkout CDER's Web page at www.fda.gov/drugs or contact the FDA's Center for Drug Evaluation and Research (CDER) directly.
CDER's Division of Drug Information can answer your questions about drugs Monday through Friday, 8:00 a.m. to 4:30 p.m., at (301) 796-3400 or at (888) INFO-FDA (463-6332).
Or contact the division via e-mail. Send your question to firstname.lastname@example.org.