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FDA commissioner calls for international inspection offices

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WASHINGTON Food and Drug Administration commissioner Andrew von Eschenbach spoke at the National Press Club on Friday, saying that the agency must increase risk-based inspections and collaborations with foreign partners as well as establish offices overseas.

The announcement comes as the FDA finds itself under fire for recent inspection mistakes made by the agency overseas. It was recently reported that the FDA mistakenly said it had inspected a plant in China that was manufacturing the blood thinner heparin. The FDA had actually taken the approved inspection from a previous inspection conducted, a practice the agency often uses.

In response, von Eschenbach has called for an initiative entitled FDA Without Borders, under which the agency will establish offices in at least five regions beginning in China. Other areas include India, the Middle East and Central and South America. The commissioner explained that the agency must work with foreign regulators to share information completely by saying, “This requires us to regulate products where they are produced,” he said. The FDA is also working on developing system called Predict, which will enhance the amount and kind of information the agency gathers, allowing it to better identify where to target resources.

The agency also plans on expanding its workforce to help with these new programs, about 700 more employees this year, according to von Eschenbach.

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