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Hospital Group Seeks FDA Actions in IV Solution Shortages

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The American Hospital Association asks the Biden Administration to require FDA to take immediate actions to increase the supply of...

Woodcock Joins Board at Drug Repurposing Nonprofit

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Former FDA principal deputy commissioner Janet Woodcock joins the board of directors at Every Cure, a nonprofit organization that ...

Respironics Recalls Trilogy Ventilators Over Nebulizers

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Philips Respironics recalls (Class 1 device correction) its Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ...

Medtronic Recalls MiniMed Pumps Over Batteries

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Medtronic recalls (Class 1) its MiniMed Insulin pumps due to concerns about reduced battery life in certain situations.

FDA Clears PlaqueIQ for Cardiovascular Disease

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An Elucid 510(k) gains clearance for its PlaqueIQ imaging analysis software to help physicians diagnose cardiovascular disease.

Thermo Fisher Plant Scrutinized by FDA: Reuters

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A Reuters article looks into drug GMP issues raised by FDA inspections over the past decade at Thermo Fisher's Greenville, NC drug...

CDRH Portal Update Tracks PMA Submissions

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FDA updates CDRHs Customer Collaboration Portal to track the progress of PMA applications and accept Small Business Determination...

Drug-Drug Interaction Assessments Lacking: FDA Research

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FDA says that 22% of new molecular entities required postmarketing requirements or postmarketing commitments to address knowledge ...

J&J Discontinues Dengue Virus Antiviral Development

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Johnson & Johnson discontinues a Phase 2 study evaluating mosnodenvir for preventing dengue virus in adults aged 18-65 years.

Tirzepatide Shortage Resolved, FDA Says

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FDA says the shortage of Lillys Mounjaro and Zepbound has been resolved but other similar products remain in short supply.