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...
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...
Removal from Import Alert 66-41: Another FDAImports.com Success Story
FDAImports.com recently obtained removal for a manufacturer from Import Alert 66-41 (automatic detention of unapproved new drugs promoted in the U.S.). Under this Import Alert FDA detains all products it deems “unapproved new drugs” – even if they’re merely cosmetics...
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...
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...
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...
Illinois Accepting Medical Marijuana Cultivation and Dispensary Applications Until Monday, September 22, 3pm
Illinois is getting its feet wet in the medical marijuana industry. The State is currently accepting applications from entities who wish to cultivate and dispense medical marijuana – a big step in implementing the Compassionate Use of Medical Cannabis Pilot Program...
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...
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...
FDAImports.com Announces Partnership with Michelson Laboratories, Inc.
FDAImports.com has announced a partnership with California-based Michelson Laboratories, Inc., a comprehensive testing laboratory which provides high-quality testing. Michelson Laboratories, Inc. has been serving clients for more than four decades and is led by...