TITLE: Center for Biologics Evaluation & Research
ACCESS: http://www.fda.gov/cber/

This Web site is the place to go to see how the United States Food and Drug Administration (FDA) regulates biological products. The Center for Biologics Evaluation and Research (CBER) oversees the production of vaccines, blood products, and cellular and tissue based products. Manufacturers of biologics, health professionals, and consumers will find helpful information on the CBER site. Topics include blood, therapeutics, vaccines, cellular and gene therapy, allergenics, and tissues. The information about each topic is comprehensive and includes background, approval, and safety information. There are links to other relevant sites for more information. The pages have been updated within the last two years; most within the last year.

The site offers a search engine powered by Google. The CBER site map is the most useful link for finding out what is available on these pages. Clicking on one of the headings on the site map or the homepage brings you to an overview of the general topic and a sidebar of specific topics.

Many of the consumer and health professional information links lead to the same documents such as "Safety Information," "FDA Patient Safety News," or "Recalls." At the consumer link however, you will find an FAQ section for background information and definitions of terms such as biologics which would be good for undergraduate students doing general research. The health professional section contains links to "Clinical Investigator Information" and "Healthcare Letters," which contains letters sent by the FDA to scientists, healthcare professionals and the biologics industry. These letters provide evidence of how the FDA's CBER arm works to regulate these products. Links to relevant regulations are included in the letters.

Researchers at all levels needing specific United States legal and regulatory information about biological products will find these pages essential. From the "Reading Room," for example, you can find links to all the documents on the CBER Web site that are available through the Freedom of Information Act. They are listed by document type such as warning letters, recalls, guides, or safety information. Undergraduate and graduate students interested in the United States' policy concerning biologics, which often include timely topics such as vaccines and gene therapy, can find useful historical and current information here.

Carol McCulley
Linfield College
cmccull@linfield.edu


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