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Baxter Recalls Buretrol Solution Sets

[ Price : $8.95]

Baxter Healthcare recalls its Buretrol Solution Sets because the devices ball-valve feature may not function as expected.

Novartis Troubled Colorado Plant Passes FDA Inspection

[ Price : $8.95]

Novartis says a troubled plant in Colorado has just received a satisfactory FDA inspection, another sign that the firm is moving f...

RedHill Reports on Pre-NDA Meeting for Anti-Migraine Drug

[ Price : $8.95]

RedHill Biopharma and IntelGenx Corp. estimate an early 2013 NDA filing for its migraine drug RHB-103 after a reported successful ...

FDA OKs Janssen 800mg Prezista HIV Tablet

[ Price : $8.95]

FDA approves a Janssen Therapeutics supplemental NDA for an 800mg tablet of Prezista (darunavir), a once-daily oral drug for treat...

Advanced Sterilization Recalls Sterrad Biological Indicators

[ Price : $8.95]

Advanced Sterilization Products recalls all lots of its Sterrad Cyclesure 24 Biological Indicators manufactured between 2/2008 and...

Guidance on Nucleic Acid Based Diagnostic Devices

[ Price : $8.95]

Federal Register Notice: FDA is making available a draft guidance, Highly Multiplexed Microbiological/Medical Countermeasure In Vi...

FDA Fast Track for Pediatric Crohns Therapy

[ Price : $8.95]

FDA awards Soligenix fast track status for SGX203 (oral beclomethasone 17, 21-dipropionate) for inducing treatment of mild-to-mode...

FDA Clears Cytomedix Angel Platelet Rich Plasma System

[ Price : $8.95]

FDA clears a Cytomedix 510(k) for its Angel Concentrated Platelet Rich Plasma System.

FDA Inspection Cites Thoratec on HeartMate II Design Validation

[ Price : $8.95]

A May FDA inspection of Thoratecs Pleasanton, CA medical device manufacturing facility finds issues with the company design valida...

Highly Multiplexed Microbiological/Medical Devices Guidance

[ Price : $8.95]

FDA publishes a draft guidance on studies for establishing performance characteristics of highly multiplexed microbiological/medic...