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Resmed Class 1 Recall of Astral Ventilators

[ Price : $8.95]

Resmed recalls its Astral 100/150 ventilator system due to the potential for a supercapacitor electrolyte leakage on the printed c...

Dr. Oz Emerges as Potential Successor to RFK Jr. at HHS, Report Says

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Bloomberg reports that Centers for Medicare & Medicaid Services head Mehmet Oz is increasingly viewed inside the Trump administrat...

Dr. Reddys Gets FDA-483 After Pre-Approval Inspection

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FDA issues Dr. Reddys a three-observation Form FDA-483 following a pre-approval inspection and Good Manufacturing Practices inspec...

FDA De Novo OK for CaRi-Heart Coronary Inflammation Technology

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FDA grants de novo authorization for Caristo Diagnostics CaRi-Heart coronary inflammation technology.

FDA Panel Votes Down Capricor's Duchenne Cell Therapy

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An FDA advisory committee votes against recommending approval for Capricor Therapeutics' investigational cell therapy deramiocel, ...

FDA Accepts for Review Saol Therapeutics SL1009 NDA Resubmission

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FDA accepts for review a Saol Therapeutics NDA resubmission for SL1009 (sodium dichloroacetate, or DCA), an investigational treatm...

5 Observations in 17-Page Strides Pharma FDA-483

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FDA releases the 17-page form FDA-483 following a May inspection at Indias Strides Pharma Science drug manufacturing facility in B...

FDA Sends Congress FY 2024 Pediatric Device Approval Report

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In its report on FY 2024 approvals of medical devices for pediatric uses, FDA says that 19 of the 56 device approvals that year we...

Novel Laboratories FDA-483 Out

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FDA releases the form FDA-483 with three observations from an inspection at the Novel Laboratories (Lupin) drug manufacturing faci...

FDA Moving to a Shared Services and Inspections Approach

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NOTUS reports that FDA will reorganize on 10/1 to a shared services model in which administrative functions are centralized, and i...