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Drug Shortage Info Updated

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FDA announces one drug shortage and resolution of another shortage.

FDA OKs Astellas Premixed Vaprisol

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FDA approves a new premixed formulation of Astellas Pharmas Vaprisol in 5% dextrose.

FDA Clears Ascents Reprocessing 510(k)

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FDA clears an Ascent Healthcare Solutions 510(k) that permits the firm to reprocess the full line of IBI diagnostic electrophysiol...

Rush is on for Botanicals, but Only 1 Approval

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CDER authors including Bob Temple describe high and rising interest in therapeutically active botanical drugs, but acknowledge tha...

FDA OKs Expanded Indication for Prezista

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FDA approves an expanded indication for Tibotec Therapeutics (an Ortho Biotech division) Prezista tablets and its once-daily dosin...

Latest FDA-483s Posted

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FDA Webview posts to our site the latest FDA-483s we have received from FDA pursuant to our FOIA requests.

FDAs Foreign Drug Inspection Program Still Flawed

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GAO says significant flaws still remain in FDAs foreign drug inspection program.

Drug Therapy-related Deaths, Injuries Up Sharply

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The Institute for Safe Medication Practices says the number of drug-related serious injuries and deaths reported to FDA was at its...

FDA Says Heplisav Risk Too Great in Healthy Patients

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FDA tells Dynavax and Merck that their investigational hepatitis B vaccine Heplisav does not have a favorable risk-benefit profile...

Quality Violations Found at Steris Isomedix

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FDA warns Steris Isomedix on Quality System violations at its medical device sterilization facility.