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FDA Wants Post-approval Study on Abbott Stent

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FDA briefing documents released before this weeks advisory committee review of Abbotts Xience drug-eluting stent support approval ...

FDA Clears Amedica Pedicle Screw System

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FDA clears an Amedica Corp. 510(k) for the Valeo Pedicle Screw System.

Latest EIRs/483s from FDA Posted

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We post to our Web site the latest FDA-483s and EIRs, etc. we have received from FDA, for Canfield Inc., GRE Fulfillment, Minntech...

FDA Signs CRADA with Ingenuity Systems

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FDA signs a cooperative research and development agreement with Ingenuity Systems to expand its content and software solutions.

Latest FDA Warning Letters

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In its latest weekly batch of posted Warning Letters, FDA cites clinical investigator Alan Rapoport.

Cardinal Recalls Alaris Pump Modules

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Cardinal Health recalls Alaris pump modules due to the potential for inaccurate flow rate from a misassembled spring.

FDA-Duke Work on Modernizing Clinical Trials

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FDA is collaborating with Duke University Medical Center on a public-private partnership to find ways to modernize clinical trials...

Fetal Risk Warning Added to Myfortic

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Novartis and FDA warn against the use of Myfortic delayed-release tablets during pregnancy due to increased risks of pregnancy los...

Guidance on Stability Testing Veterinary Drugs

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Federal Register Notice: FDA releases an ICH revised guidance on stability testing of new veterinary drug substances and medicinal...

Guidance on Impurities in Veterinary Substances

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Federal Register Notice: FDA releases a revised ICH guidance on impurities in new veterinary drug substances.