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The action by the regulatory agency falls under the Generic Drug User Fee Amendments of 2012. "Placing these firms on import alerts is the first time the FDA is using the authority provided by Congress to enforce GDUFA's user fee provisions," Kris Baumgartner, an agency spokesman, told the Regulatory Affairs Professionals Society’s publication Focus.
Named by the FDA to the ban are Jiangsu ZW Pharmaceuticals and Wuxi Kaili Pharmaceutical, both of China and both of which received warning letters in 2015; and Fleming Laboratories and Sharon Bio-Medicine, both of India. Fleming got an FDA warning letter in 2014, and Sharon Bio-Medicine in 2015.
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