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bioMrieux Respiratory/Sore Throat Panel Cleared

[ Price : $8.95]

FDA clears a bioMrieux 510(k) for its Biofire Spotfire Respiratory/Sore Throat Panel Mini for detecting five of the most common vi...

Aurobindo Recalls Healthy Living Migraine Relief

[ Price : $8.95]

FDA says Aurobindo has recalled one lot of its OTC Healthy Living migraine medication that was distributed through Amazon without ...

VICH Residual Solvents Guidance

[ Price : $8.95]

FDA publishes a Veterinary International Conference on Harmonization revised guidance on residual solvents used in animal drugs.

Guide on e-Health Records to Support Submissions

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Real-World Data: Assessing Electronic Health Records and Me...

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

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Two stakeholders call for changes to an FDA draft guidance on safety testing of human allogeneic cells expanded for use in cell-ba...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