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Law Librarians of New England

a chapter of the American Association of Law Libraries

CyberCites
Pharmacy Law

Food and Drug Administration Center for Drug Evaluation and Research
www.fda.gov/cder/

The purpose of the FDA’s Center for Drug Evaluation and Research (CDER) is to assure that safe and effective drugs are available to the public. Users can easily locate Drug Approvals (CDER New and Generic Drug Approvals 1998-2001) via a browsable chart, and the Electronic Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). CDER posts warning letters and notice of violation letters to pharmaceutical companies. Most useful is that researchers can subscribe to a variety of CDER daily or weekly e-mail lists free of charge.

The FDA’s Recalls and Safety Alerts site provides up-to-date information on drug recalls and safety alerts. Product recalls and safety alerts announced over the past 60 days are listed, while various archives include alerts since 1990. Click on the bottom of the page for the link to the FDA homepage. There, users can access MedWatch, a current awareness service of the FDA Safety Information and Adverse Reporting Program. Safety information is grouped into two groups: (1) drugs, biologics, devices, and dietary supplements; and (2) drug labeling changes. A link is provided to relevant articles and publications, and most helpful is the MedWatch e-list where researchers can subscribe to receive medical product safety alerts delivered via e-mail.

Pharmacy researchers will find WebMD a convenient site to access, although it is generally known as a provider of consumer-oriented health information. Click on “Drugs and Herbs” for information on prescription medications, over-the-counter medications, and herbal remedies. Researchers may utilize the search engine or just browse through the alphabetical listing to read encyclopedic entries. Also accessible is FDA information, such as the latest FDA Drug Alerts, Product Recalls, New Drug announcements, and FAQs regarding drug questions.

Several of the American Pharmaceutical Association’s publications are available on this site, such as the Journal of the American Pharmaceutical Association (JAPhA) and Pharmacy Today. The current issue of Pharmacy Today is online in summary form only; however, JAPhA is provided back to Nov./Dec. 1998 by table of contents and by abstract, with recent issues available full text. Most helpful is an extensive collection of pharmacy practice websites that provide a great starting point for the researcher.

A variety of drugs or dietary supplements are listed on this website with the actions taken regarding their safety. Examples are Fen-Phen, Ephedra, and Celebrex. The researcher is provided with an overview of the litigation, along with links to websites focusing on the drug litigation. Findlaw provides newsletters to notify researchers about current class action news. Subscribe to Class Action and Recall News and Class Action Case summaries by filling out a subscription form at this website.