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Abbott's New Glucose Test Strips Are First To Address Fatal Product Flaw

This article was originally published in The Gray Sheet

Executive Summary

With a little extra push from FDA, Abbott gained 510(k) clearance May 14 for its new FreeStyle Lite blood glucose test strips, designed to remedy a potentially life threatening flaw in the product

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Regulatory News In Brief

Post-inspection response program: Beginning Sept. 15, FDA will consider industry responses to Form 483 inspection reports received within 15 days of the report's release when deciding whether to send a warning letter, FDA explains in an Aug. 11 Federal Register 1notice. Timely responses do not preclude FDA from issuing a warning letter. FDA Commissioner Margaret Hamburg announced the 15-day post-inspection deadline for company responses to FDA's inspection findings at a Food and Drug Law Institute meeting Aug. 6 (2"The Gray Sheet" Aug. 10, 2009). FDA plans to test out the response review program for 18 months and then decide whether to implement it permanently

99 Days Until MDR: Time Is Running Out For Medtech As Risky, Volatile Future Looms

The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.

BrightGene Bets On Remdesivir Amid Patent Questions

Despite many uncertainties, Suzhou-based BrightGene sees a bet on generic remdesivir worthy of a $700,000 investment.





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