TITLE: Center for Drug Evaluation and Research

Access: http://www.fda.gov/cder/index.html

With the seemingly ever-increasing amount of drug advertising currently in the media, a tool with solid, factual information about drugs in needed. The Center for Drug Evaluation Research (CDER) Web site is an easy-to-use, searchable source of drug information for both consumers and medical professionals. CDER is part of the U.S. Food and Drug Administration (FDA) and its mission is "to assure that safe and effective drugs are available to the American people." The CDERs primary duties are to evaluate new drugs, approve clinical trials, carefully review drug manufacturers' research, and decide if a drug is approved for public use.

One of the most useful parts of the site is "Drugs@FDA," a searchable database with official FDA information about generic, prescription, over-the-counter, and discontinued drugs. Users can browse or search by a drug's name or active ingredients. They can also do an advanced search by application number or approval dates. The database contains information including strength, dosage form, status, manufacturing company, similar drugs, ingredients, and FDA-approved labeling. It also includes documents, in PDF format, about the drug's approval history, manufacturing, and packaging. There is a glossary and instructions for searching. "Drugs@FDA" contains information similar to the Physicians' Desk Reference.

"What's New @ CDER" lists FDA approvals, recalls, drug label revisions, and warnings. Users can subscribe to daily or weekly e-mail updates. The site has information on buying and using drugs, drug shortages, an inactive ingredient database, a post-marketing study commitments database, drug information sheets prepared by pharmacists, and the National Drug Code Directory. Users can search the Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations, to find alternative medications with the same active ingredients. The Web site also contains information about hot topics such as botanical drugs, bioterrorism, biological therapeutic products, and the drug approval process. It has information about CDER's offices, divisions, and current personnel, as well as its 90-year history.

The Web site can be confusing with sections such as "Who We Are" and "What We Do" that supply links instead of the information itself. In addition, most documents are labeled with the date they were posted, but users must check carefully as the dates vary widely, and some documents are over ten years old. Some documents are also available in Spanish. The site search is powered by Google.

Overall, the site is user-friendly and contains valuable information about all human drugs. The CDER Web site is recommended for students, faculty, professionals, and consumers who need current information about generic, over-the-counter, or prescription drugs.

Kate Peterson
California State University, Long Beach
jpeters4@csulb.edu


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