FDA Imports

FDAImports.com and AMCHAM Colombia

In October, FDAImports.com Partner Rick Quinn attended an event with the American Chamber of Commerce in Colombia and spoke about the regulatory basics of exporting to the United States. Mr. Quinn explained the regulatory agencies involved in imports in the U.S.,...

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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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