Regulatory controls for 13 importing drugmakers relaxed by U.S. FDA

02/19/2014 | Hill, The

Regulatory controls are being loosened by the U.S. FDA for 13 "highly vetted" drugmakers that will get expedited entry for medicines they are importing into the U.S. The firms will assume greater accountability for regulating their own supply chains as part of the Secure Supply Chain Pilot Program, allowing the FDA to concentrate on stopping adulterated, misbranded and unapproved medicines from entering the country. "We're still going to be looking at them, but we have a greater degree of confidence that their drugs are not going to need to be as thoroughly vetted as others," said FDA spokesman Christopher Kelly.

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Hill, The

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