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CDRH Working to Reduce Medical Device Misconnections

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CDRH says it is working with standards organizations, federal partners, professional societies, advocacy groups, patients and othe...

Microbiology Devices Panel to Meet 11/9-10

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Federal Register Notice: FDA annouces an 11/9-10 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting in G...

Workshop on Semantic Interoperability of Lab Data

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Federal Register Notice: FDA and other government agencies host an 11/8 public workshop on Promoting Semantic Interoperability of ...

FDA/CMS Parallel Review is a Bust: New Study

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A new study finds FDA and CMSs parallel review program has fallen short and failed to address the real obstacles manufacturers fac...

Workshop Planned on Semantic Interoperability of Lab Data

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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...