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Human Drugs

Hospital Group Seeks FDA Actions in IV Solution Shortages

The American Hospital Association asks the Biden Administration to require FDA to take immediate actions to increase the supply of intravenous (IV) so...

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Human Drugs

Woodcock Joins Board at Drug Repurposing Nonprofit

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

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Medical Devices

Respironics Recalls Trilogy Ventilators Over Nebulizers

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

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Human Drugs

Clinical Hold Slapped on Kezar Lupus Trial

FDA orders a clinical hold on Kezar Life Sciences IND for zetomipzomib and its investigational use in treating lupus nephritis.

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Human Drugs

Sublocade Priority Review for Expanded Labeling

FDA awards a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection for treating moderate ...

Medical Devices

AdvaMed Seeks FDA Best Practice on Trial Diversity

AdvaMed says that as FDA begins receiving and reviewing diversity action plans, it should publicly disclose any key best practices it identifies.

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Human Drugs

Comments Sought on Pharmaceutical Quality Terminology

FDA requests comments on a draft document about controlled terminology/vocabulary that applies to a set of coded quality attribute data elements for t...

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Medical Devices

Medtronic Recalls MiniMed Pumps Over Batteries

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

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Medical Devices

FDA Clears PlaqueIQ for Cardiovascular Disease

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

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Human Drugs

Thermo Fisher Plant Scrutinized by FDA: Reuters

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