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PolyPid NDA Accepted for Preventing Surgical Site Infection

[ Price : $8.95]

FDA accepts for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infections in patients undergoing ...

FDA Posts User Fee Rates for FY 2027

[ Price : $8.95]

FDA posts the following user fee rates for medical product programs for fiscal year 2027.

9 Items on Bentley Laboratories FDA-483

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FDA releases the form FDA-483 with nine observations from an inspection at the Edison, NJ-based Bentley Laboratories over-the-coun...

Resmed Class 1 Recall of Astral Ventilators

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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, ...

New Effectiveness Evidence Requirements Analyzed

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Two Latham Watkins attorneys analyze a revised FDA draft guidance on demonstrating substantial evidence of effectiveness in drug a...

Allure Labs FDA-483 Out

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FDA releases the form FDA-483 with three observations from an inspection at the Hayward, CA-based Allure Labs drug manufacturing f...