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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Regulatory Highlight: FDASIA

The Food and Drug Administration Safety and Innovation Act (FDASIA) turned two years old in July, marking the end of the second year of its three-year implementation plan.  This act, which focused primarily on adding and improving regulation of drugs and medical...

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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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FDAImports.com and Defining Natural at Expo East 2014

This year at Natural Products Expo East 2014, in Baltimore, MD, September 17-20, FDAImports.com Partner Rick Quinn will be participating in the Retailer Town Hall Discussion entitled “Defining Natural.”  Mr. Quinn has been an integral part of this discussion at Expo...

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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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