Imports

GDUFA Fees Increased – and Won’t Stop Anytime Soon

While generic drug laws and policy have brought down the cost of Rx drugs for many Americans, recent legislation, such as the Generic Drug User Fee Amendments of 2012 (GDUFA) is reversing that trend and significantly increasing the cost of generic drugs.  GDUFA added...

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It’s Not Just FDA You Have to Watch out for…

Chinese companies exporting foods, drugs or medical devices to the USA: be aware!  FDAImports.com has recently learned China’s FDA inspections include verifying the U.S. FDA registrations of Chinese manufacturers. China FDA is not just verifying companies have valid...

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Successful Webinar: Preventive Care for Import Compliance

Benjamin England, FDAImports.com Founder and CEO recently presented a webinar with FDANews, entitled “Thinking Ahead of FDA: Preventive care tips for your FDA import compliance program.” Mr. England said, “Up to now, FDA has been mostly reactionary in its enforcement...

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The Burden of Reinspection Fees Who Can Bear?

UPDATE 03/02/2017 FDA’s Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates are out for FY 2017. The domestic reinspection rate was not changed from the 2016 rate. Surprisingly, the foreign reinspection rate, which has been...

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Switching Sweets: Economic Adulteration Webinar

Benjamin England, FDAImports.com Founder and CEO recently presented a webinar with Eurofins Scientific, entitled “Switching Sweets: Economic Adulteration in Sugar-Rich Foods.” The webinar addressed the issue of producers substituting cheap ingredients and advertising...

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Honey and Sweetener: Coexisting No Longer

Last month, FDA issued a new Draft Guidance, requiring the labels of honey products to declare sweeteners in the statement of identity. This sounds ridiculous. Consumers have accepted that honey marketers routinely mix honey and sweeteners – for example, sugar or corn...

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