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The US Food and Drug Administration (Rockville, MA, www.fda.gov) commemorated its 100th anniversary in 2006 as America's premier public health agency aimed at protecting and promoting public health.
The US Food and Drug Administration (Rockville, MA, www.fda.gov) commemorated its 100th anniversary in 2006 as America's premier public health agency aimed at protecting and promoting public health. To accomplish this mission, the three FDA line organizations that regulate healthcare products-Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH)-streamlined and improved their processes last year.
In 2006, CDER approved a total of 101 new products, including 97 new drug applications (NDAs) and 4 biologic license applications (BLAs) for brand-name therapeutic products. Twenty-two (18 NDAs and 4 BLAs) of these products were new molecular entities (NMEs)-medications whose active ingredients are new on the US market. In addition, CDER approved or tentatively approved 535 abbreviated new applications (ANDAs) for generic versions of brand name medications.
In 2006, CBER approved 10 new BLAs. Three of these products received priority reviews in the median time of 6.4 months. The remaining 7 new BLAs received standard reviews in the median time of 13 months. CBER also approved 7 supplemental applications for additional product indications, routes of administration, dosage formulation, or product improvements.
CBER's major approvals included the following vaccines: Gardasil, the first biological product to prevent cervical cancer; Zostavax, to reduce the risk of shingles (herpes zoster) in people over the age of 60; RotaTeq, for the prevention of rotavirus gastroenteritis infection in infants and children; and FluLaval, to help prevent influenza. Other medically significant new approvals included Vivaglobin, for the prevention of serious infections in patients with Primary Immune Deficiency Disease; and ORTHO T. cruzi Elisa Test System to screen blood, tissue, and organ donors for antibodies to the parasite that causes Chagas disease.