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...
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...
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...
The Dietary Supplement and Nonprescription Drug Consumer Protection Act amended the FFDCA to subject those OTC drugs marketed without an approved NDA or ANDA to OTC drug reporting requirements, which had previously only applied to those OTC drugs with an approved...
Intending to close the frequency gap between foreign and domestic inspections, FDA has been increasing its foreign inspections, especially at drug plants in India. India is FDA’s current top priority, as it has the largest number of drug manufacturers and is a major...
Approximately 90% of “antibacterial” or “antimicrobial” soaps currently on the market are made with the active ingredient triclosan, a chemical known to kill bacteria. For obvious reasons, consumers generally consider these soaps more effective than plain soap and...
Myth 1: DQSA grants the FDA sweeping authority in determining what pharmacies can compound. Compounding sophisticated, difficult-to-produce drugs will not be prohibited. Traditional compounding pharmacies – those small operations which compound drugs that fill...
Benjamin England, FDAImports.com Founder and CEO, and Bill Nychis, Senior Regulatory Advisor, recently co-presented a webinar entitled “FDA Import Holds: New Powers to Control Products.” Mr. England provided an overview of FDA’s drug importation enforcement authority,...
For decades, FDA and the States’ jurisdiction over compounding were at odds. Compounding has traditionally been governed by the States, and pharmacists could supply patients with compounded drugs without needing FDA’s approval. The controversial Drug Quality and...
An outbreak of fungal meningitis, traced to contamination in compounded injectable steroids, jump-started the movement to increase federal authority over compounding operations. Now, federal oversight is about to increase, with the President expected to sign into law...
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