Your SOPs and the UDI Regulations: December 23 Deadline

Device manufacturers take note: Changes in regulations accompanying the Unique Device Identifier (UDI) regulation took effect on December 23, 2013. The new UDI regulations reach far and wide. In addition to creating a new regulation at 21 CFR 830, changes also...

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Antibacterial Soaps: Can Makers Prove Them Effective?

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...

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FDAImports.com at Natural Products Expo West 2014

FDAImports.com is excited to attend and participate in Natural Products Expo West again this year, meeting and talking with many industry members involved in bringing natural products to the United States market.  We are looking forward to joining the discussion on...

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Import Duties on Warm-Water Shrimp from India

Last month, FDAImports.com attended the Chennai Seafood Show, where we had the pleasure of meeting and talking with many members of the Indian seafood industry.  The industry is very interested in finding clarification on duties, rebates, and preferential rates –...

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FDAImports.com at the Chennai Seafood Show

FDAImports.com recently attended and presented at the 2014 India International Seafood Show in Chennai. Principal Rick Quinn and India Country Director Shanmugam Jayakumar met with processors, exporters, and industry members at the FDAImports.com booth, discussing the...

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FDAImports.com to Attend India Seafood Show in Chennai

Rick D. Quinn, Principal of FDAImports.com, will be attending the India International Seafood Show, January 10-12, 2014, in Chennai, India, along with Mr. Shanmugam Jayakumar, FDAImports.com's India Country Director, will be exhibiting at the show for the first time...

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Import Alert Listings: Not Just for Tested Product Anymore

Look out, industry: there’s a new way to get put on Import Alert.  FDA is beginning to place firms on import alert based on traceability data collected by FDA and the Center for Disease Control and Prevention (CDC).  Firms used to think they would only end up on...

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The Myths and Truths of the Bill on Drug Compounding

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...

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