FDA Perspective

Online Information for Health Care Professionals



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Am Fam Physician. 2000 Dec 1;62(11):2528-2530.

The home page of the U.S. Food and Drug Administration (http://www.fda.gov) has undergone a major revision. The agency's Web site, which includes more than 100,000 documents, is now easier to search and covers the full scope of the FDA's activities in protecting the public health by regulating food, human and animal drugs, vaccines and blood products, medical devices and cosmetics. In addition to the agency's own information, the site contains links to Web sites of many other government and private organizations associated with public health.

The site is designed to increase the agency's effectiveness by achieving three goals: maximizing the availability of public health information, improving the public's knowledge about FDA operations and strengthening the agency's communication and cooperation with the rest of the health care community. In selecting the online data, the FDA has made a special effort to include information of special interest to physicians, who share the FDA's responsibility for managing public health risks.

The following overview summarizes the FDA's online information for health care professionals.

Information for Health Professionals (http://www.fda.gov/oc/oha/default.htm)

This page is an entry point for health care professionals. It has links to a variety of medical topics, including ongoing clinical trials and measures for the protection of human subjects; drug control, scheduling and addiction treatment; alternative/complementary medicine; FDA publications for health care professionals; and hot links and telephone numbers for FDA centers and offices that can answer specific questions about drugs, biologic products, medical devices and orphan products. Links from this page describe where to report adverse reactions (http://www.fda.gov/medwatch/); how to submit electronic records to the FDA; news from the global health arena; and how to apply for a job with the FDA.

Oncology Tools (http://www.fda.gov/cder/cancer/tour.htm)

The large oncology site offers a search engine that covers a broad spectrum of cancer-related subjects. The site, which can be accessed from the home page of the FDA's Center for Drug Evaluation and Research (http://www.fda.gov/cder) includes information about how to obtain experimental drugs; how to file an application to test an investigational drug; some of the assessment tools for conducting clinical investigations; scales for assessing patient performance status; standard tables to describe adverse events; and calculators for human and animal dosing, and human fluid requirements.

The site also includes links to the list of FDA-approved oncology drugs; extensive coverage of disease summaries and cancer information from the National Cancer Institute, universities in the United States, and leading European cancer institutions; oncology reference tools, including common toxicity criteria, disease staging manual, FDA regulations about access to unapproved drugs; FDA's cancer patient liaison program; and information about cancer institutes and hospitals, cancer-oriented legislative initiatives, specialized literature and other resources.

Pediatric Medicine (http://www.fda.gov/pediatrics)

This page describes the FDA's implementation of a program that provides incentives for pediatric studies of drugs approved for use in adults. The information includes pertinent FDA regulations, policies and guidances; requests for pediatric studies; recently adopted pediatric labeling changes; frequently asked questions about pediatric exclusivity; and a list of approved drugs for which additional pediatric information may produce health benefits for children.

In addition, the site provides information about meetings and conferences that focus on pediatrics, with presentation summaries and transcripts; presentations of pediatric issues given by FDA's specialists; and links to other Web pages, including those of the American Academy of Pediatrics and the National Institute of Child Health and Human Development.

Drug Information (http://www.fda.gov/cder/drug/default.htm)

This page, which has a search engine, presents two categories of drug information: a description of FDA-labeled drugs and extensive information about drug safety. The former material includes a daily updated list of new and generic drug approvals from 1998 with their labels, approval letters and reviews; a chronologic listing of all drugs approved since September 1996; and a list of new drugs approved for cancer indications. In addition, the site includes a link to FDA's searchable Orange Book,1 with all FDA-approved prescription drugs, newly approved generic drugs and supplemental indications; the National Drug Code Directory; detailed information about major drugs approved since 1998; information about drug shortages; and information about nonprescription drugs.

The drug safety section discusses labeling changes related to drug safety, the FDA's public health alerts, warning letters and notices of violations; and includes a link to MedWatch, the Web site for the FDA's medical products reporting system. The Drug Information page also provides information about clinical trials for medications to treat acquired immunodeficiency syndrome (AIDS) and cancer; human immunodeficiency virus (HIV) drug approvals; and an alphabetic listing of cancer-oriented organizations.

Biologic Products (http://www.fda.gov/cber/products.htm)

The Web page of the FDA's Center for Biologics Evaluation and Research (CBER) includes a product information section with instructions about how to report adverse events associated with vaccines (http://www.fda.gov/cber/vaers/vaers.htm), blood transfusions (http://www.fda.gov/cber/transfusion.htm) and other biologic agents (http://www.fda.gov/medwatch/); a list of licensed biologics and biologic facilities; information on biologic devices and licensed/approved tests for HIV, human T-cell lymphotropic virus types I and II and hepatitis; and designations for orphan products. A sizable section on safety issues includes all biologic product recalls and withdrawals, product quarantines, drug shortages and important warnings that have been issued to health care professionals since January 1, 1998.

Medical Devices (http://www.fda.gov/medicaldevices/default.htm)

The site of the FDA's Center for Devices and Radiological Health has a search engine and a Web page containing searchable databases (http://www.fda.gov/cdrh/databases.html). The databases include premarket approvals of class III medical devices; cleared premarket notifications of class II and III devices; and information on adverse events associated with medical devices. A “Special Interest” section includes the texts of safety alerts, public health advisories and notices from the Center since June 1983; a “Reducing Use Error” section on human factors that includes an e-mail address and forms for reporting difficulty in using medical equipment (http://www.fda.gov/cdrh/useerror/Index.html); and a “Radiological Health” section that lists all FDA-certified mammography facilities in the United States (http://www.fda.gov/cdrh/mammography/certified.html). Other sites with links to the “Special Interest” section present FDA rules on the use of reprocessed devices labeled “for single use only,” comprehensive information about breast implants and a site on “CDRH Research Areas” (http://www.fda.gov/cdrh/research.html), with information about radiation-induced skin injuries from fluoroscopy and how to avoid them.

Food Safety (http://www.fda.gov/Food)

The Web page of the FDA's Center for Food Safety and Applied Nutrition (CFSAN) offers information on several topics of interest to physicians. A section on “Foodborne Illness” contains extensive discussion of foodborne pathogens, toxins and other contaminants. A link to the Government Food Safety Information Gateway (www.foodsafety.gov) contains useful information for health practitioners and their patients, including how to report illnesses and product complaints. A section on “Dietary Supplements” includes FDA warnings and safety information about numerous dietary supplements or ingredients in dietary supplement products. The site gives instructions for reporting food-associated adverse events (http://www.fda.gov/medwatch/how.htm) and using the Web report on FDA's special nutritionals adverse event monitoring system, which includes adverse event information for dietary supplements, infant formulas and medical foods. The “Special Interests Areas” section contains information targeted to specific groups, including women and senior citizens, which physicians may find useful for answering patient questions.

Cosmetics (http://www.fda.gov/Cosmetics)

Information about the safety of cosmetics is also accessible from the Web page of the Center for Food Safety and Applied Nutrition, which regulates these products. The site contains data on the safety of various products, including hair spray and color additives; the results of two recently completed FDA-sponsored clinical trials investigating the safety of alpha hydroxy acids; consumer complaints about cosmetics over the previous five years; and instructions about how to report problems with cosmetic products.

William M. Rados, M.A., is the Web site manager for the U.S. Food and Drug Administration.

REFERENCE

1. U.S. Department of Health and Human Services. Approved drug products with therapeutic equivalence evaluations. 20th ed. Rockville, Md.: U.S. Food and Drug Administration, 2000.

Coordinator of this quarterly series from the U.S. Food and Drug Administration is Mike Kubic of the Office of Public Affairs.


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