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Workshop Planned on Semantic Interoperability of Lab Data

[ Price : $8.95]

FDA and other government agencies plan an 11/8 public workshop on Promoting Semantic Interoperability of Laboratory Data that is i...

Baxter Recalls Compounding Filters

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Baxter International recalls all unexpired lots of 50mm 0.2 micron filters (product code H93835) due to the potential for a missin...

CDER Report Outlines Drug Safety Research Priorities

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A new CDER drug safety report outlines ongoing research priorities to improve drug safety.

FDA Denies Petition for Action on Unapproved Potassium Chloride

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FDA denies a citizen petition that asked FDA for immediate enforcement action against unapproved potassium chloride oral solution ...

Woodcock Unfit to be CDER Director: Public Citizen

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Public Citizen Health Research Group director Michael Carome says CDER director Janet Woodcock is unfit to serve as CDER director....

Jazz Begins Rolling NDA for Leukemia Drug Vyxeos

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Jazz Pharmaceuticals begins a rolling NDA submission for Vyxeos (cytarabine and daunorubicin liposome injection), an investigation...

Par Sues FDA Over Colchicine Exclusivity Forfeiture

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Par Pharmaceutical files a lawsuit in DC federal court against FDA seeking reversal of an agency decision that revoked Pars eligib...

Lehigh Valley Tech Seeks Action Against Virtus Pharma

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Lehigh Valley Technologies petitions FDA asking it to take enforcement action against Virtus Pharmaceuticals Holdings and to remov...

Evoked Photon Image Capture Device into Class 1

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Federal Register Final Order: FDA classifies the Evoked Photon Image Capture Device into Class 1 (general controls).

FDA Amends Animal Drug Regs for Approvals, Etc.

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Federal Register Final Rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug app...