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One in a Series of Information Sheets from FDA
The nation's more than $40 billion annual investment in biomolecular research is fueling a deluge of promising new medications that will eventually land at the FDA's door, seeking approval to enter the market. For many of the most exotic treatments-from cellular replacement therapies to animal organ transplants-the gate-keeper is the Center for Biologics Evaluation and Research (CBER).
CBER regulates biological products for disease prevention and treatment that are inherently more complex than chemically synthesized pharmaceuticals, including:
These and other biological products have the potential to provide immense public
health benefits, and they are being developed at an annual rate that has increased
from 350 in 1990 to more than 650 in 2000.
In addition, CBER's scientists are prepared to evaluate the safety and effectiveness
of products that will result from the most complex and exciting areas of biomedical
research, including:
For more information, please call CBER at 1-800-835-4709 or 301-827-2000, or visit the FDA Web site at www.fda.gov/cber.
CBER plays an integral role in several initiatives to protect the Nation against bioterrorism. The Center is helping to advance the development and licensing of products to diagnose, treat, or prevent outbreaks from exposure to bioterrorist pathogens by entering the process at an early stage and helping the products to rapidly meet the regulatory requirements. The Center also is developing procedures and protocols to make possible the safe use of promising experimental products when there is no approved medication for the treatment of victims of terrorism.
Publication No. FS 01-4
Revised: February 2002