What's on the FDA fast track?

An occasional snapshot of current facts and trends in medicine.

Quick View. Posted April 17, 2006

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A significant number of drugs are making a quick move to the market.

Among the findings of the March/April Impact Report published by Tufts Center for the Study of Drug Development is the fact that cancer-related programs receive the lion's share of fast-track designations, about 40%.

HIV/AIDS drugs, which had accounted for 20% of all such designations in 2001, dropped to 8% in 2005.

From 1998 to 2005, the Food and Drug Administration awarded nearly 500 fast-track designations to drugs it determined addressed unmet medical needs for serious conditions. Such drugs represented nearly 20% of all active investigational compounds in clinical development programs worldwide during that time. The fast-track program was launched in 1997 in the United States and is being duplicated in Europe, China and Japan.

The therapeutic area mix of fast-track designations outside of cancer and HIV/AIDS has changed little since 2003.

Overall, more than 100 diseases and conditions have received fast-track designations, including those that represent urgent public health needs -- bioterror countermeasures, pandemic threats and neglected diseases.

Source: March/April Impact Report, Tufts Center for the Study of Drug Development

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