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Medtronic Recalls NIM Vital Nerve Monitor

[ Price : $8.95]

Medtronics Xomed unit recalls (Class 1) its NIM Vital Nerve Monitoring system due to the potential for false negative responses.

Covid-19 Convalescent Plasma Guidance

[ Price : $8.95]

FDA publishes an immediately effective guidance with its recommendations for investigational and licensed Covid-19 convalescent pl...

Recommend Transition to HTS Technology: MIT Letter

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Two stakeholders call for changes to an FDA draft guidance on safety testing of human allogeneic cells expanded for use in cell-ba...

House FDA Budget Bill Floor Vote Scrapped

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House Republican leaders postpone a floor vote this week on FDAs fiscal year 2025 budget.

Mirums Livmarli Gets Expanded Label

[ Price : $8.95]

FDA approves a Mirum Pharmaceuticals label expansion for Livmarli (maralixibat) oral solution for treating cholestatic pruritus in...

Abbott Recalls FreeStyle Libre 3 Sensors

[ Price : $8.95]

Abbott begins a medical device correction for some of its FreeStyle Libre 3 sensors due to potential incorrect high glucose readin...

FDA Fast Track for AC Immune Alzheimers Drug

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FDA grants fast-track designation to AC Immunes investigational candidate being developed with Janssen for Alzheimers disease.

Shuren Retiring; Tarver is Acting CDRH Director

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CDRH director Jeff Shuren says he is retiring later this year and deputy Center director for transformation Michelle Tarver will s...

FDA Wants Host Cell Protein Immunogenicity Info

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FDA establishes a docket for information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins.

Biocon Biosphere FDA-483

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FDA releases the form FDA-483 with three observations from an inspection at Biocon Biosphere in Andhra Pradesh, India.