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FDA 101: Biological Products

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Biological products often represent the cutting edge of medical science and research. Also known as biologics, these products replicate natural substances such as enzymes, antibodies, or hormones in our bodies.

Biological products can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as cells and tissues. Biologics are made from a variety of natural resources—human, animal, and microorganism—and may be produced by biotechnology methods.

Gene-based and cellular biologics, at the forefront of biomedical research today, may make it possible to treat a variety of medical conditions, including illnesses for which no other treatments are available. Research continues to develop more biologics that will help treat medical conditions or add to existing treatment options.

Here are answers to some frequently asked questions about this diverse and highly important field.

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What biological products does FDA regulate?

The Center for Biologics Evaluation and Research (CBER) within FDA regulates a wide range of biological products, including

The Center for Drug Evaluation and Research (CDER) within FDA regulates other categories of biological products mostly produced by biotechnology methods, including:

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How do biologics differ from conventional drugs?

Most drugs consist of pure chemical substances and their structures are known. Most biologics, however, are complex mixtures that are not easily identified or characterized. Biological products differ from conventional drugs in that they tend to be heat-sensitive and susceptible to microbial contamination. This requires sterile processes to be applied from initial manufacturing steps.

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What is FDA's role regarding biological products?

FDA's regulatory authority for the approval of biologics resides in the Public Health Service Act (PHS). However, biologics are also subject to regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because most biological products also meet the definition of "drugs" cited within this Act.

Similarly, some medical devices used to produce biologics are regulated by CBER under the FD&C Act's Medical Device Amendments of 1976.

FDA also

The PHS Act also

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What are the responsibilities of a licensed biologics manufacturer?

The PHS Act requires individuals or companies who manufacture biologics for introduction into interstate commerce to hold a license for the products. These licenses are issued by FDA.

Some responsibilities of a licensed biologics manufacturer include

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How can adverse events related to biologic products be reported?

Contact FDA's MedWatch program at www.fda.gov/medwatch/

For vaccines, contact the Vaccine Adverse Event Reporting System (VAERS) at www.fda.gov/cber/vaers/vaers.htm

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest on all FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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For More Information

FDA's Center for Biologics Evaluation and Research (CBER)

Therapeutic Biological Products (CDER)

Have You Given Blood Lately?

FDA 101: Human Gene Therapy

A Parent's Guide to Kids' Vaccines

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Date Posted: June 26, 2008
Updated: July 25, 2008

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