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Look at How Policies Affect Drug Development: PhRMA

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PhRMA president John Castellani says its important to consider how public policies may affect patient care and drug development in...

Fabius Anesthesia Machines Recalled

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FDA says Drger is recalling specific Fabius anesthesia machine units that may have a power supply problem.

Hospira Recalls 1 Lot of Injectable Lidocaine

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In its sixth such action since May, Hospira recalls one lot of 1% lidocaine HCI injection due to a confirmed customer report of vi...

QS Violations Found at Batrik Medical

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FDA warns Batrick Medical about Quality System violations in its manufacturing of vascular silicon ties.

Court Dismisses Hip Replacement Suit Against DePuy

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A Pennsylvania federal court dismisses a suit against DePuy Orthopedics alleging injuries due to a defective replacement hip.

FDA Clears Advanced Catheter for Occlusion Perfusion Catheter

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FDA clears an Advanced Catheter Therapies 510(k) for its Occlusion Perfusion Catheter.

Inspection Finds QS Violations at Japans Nidek Company

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FDA warns Japans Nidek Co. about Quality System violations in its manufacturing of non-sterile laser devices.

Boston Scientific Catheter Scores Well in Clinical Trial

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Boston Scientific says a clinical trial of its OffRoad Re-entry catheter system performed better than pre-specified trial goals.

FDA Probing Hepatitis Cases Linked to OxyElite Pro

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FDA says it is working with CDC and the Hawaii Health Department to investigate cases of acute non-viral hepatitis in Hawaii that ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Anji Zheng Bang Medical Instruments, Batrik Medical Mfg., and Nidek Co.