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Pilot Program to Improve Drug Safety

Tue, 01/27/2009 - 17:24
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(FDA: Rockville, Maryland) -- In an effort to combat counterfeiting and contamination, the Food and Drug Administration (FDA) is launching a voluntary pilot program for drug makers to determine the practicality of developing a secure supply chain program.

The goal of the program is to allow the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant. It will also expedite the entry of products meeting the pilot’s criteria into the United States.

Concern about imported drug ingredients grew last year after the deaths of patients given tainted supplies of the blood-thinner heparin made in China. “With the increase of drug products produced outside the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don’t meet the FDA’s standards and violate U.S. laws,” says Michael Chappell, acting associate commissioner for regulatory affairs at FDA.

To qualify, applicants will need to meet the pilot’s criteria:

 …

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