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U.S. Speeding Bioterrorism Medication Development

Global Security Newswire

The U.S. Food and Drug Administration has increasingly placed countermeasures against bioterrorism and natural pandemics on the fast track for approval, FDA Week reported Friday (see GSN, Jan. 20).

Fast-track status can be given to drugs that fill unmet medical needs or that treat life-threatening and serious diseases, according to FDA Week.

Fears about a biological weapons attack and pandemic flu have changed the way an unmet need is defined, according to Christopher Paul-Milne, assistant director of the Tufts University Center for the Study of Drug Development. For example, although smallpox no longer exists in nature, the government wants to be prepared if the disease is used in a terrorist attack.

Milne said he believes that the fast track approval process is working. A report by Tufts University found that despite often being harder to develop, drugs on the fast track are ready in the same amount of time as less-complicated medications (FDA Week, March 10).

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