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Judge Strikes Down FDA Decision Blocking Priority Voucher

[ Price : $8.95]

A Washington, DC, federal judge rules that FDA acted unlawfully when it denied a priority review voucher to Sun Pharma and its dru...

New CDER Director Pazdur Files Retirement Papers

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Weeks into his new appointment, CDER director Richard Pazdur files paperwork to retire by the end of the month.

FDA Alert on Abbott Glucose Monitor Sensors

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FDA issues an early alert concerning certain Abbott Diabetes Care glucose monitor sensors, warning patients and healthcare provide...

Hi-Tech Pharma CEO Convicted in GMP Fraud Scheme

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Government prosecutors win guilty conviction against Hi-Tech Pharmaceuticals CEO and twice-convicted felon Jared Wheat for orchest...

FDA Safety Alert on Some BD Alaris Pump Modules

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FDA issues a safety alert after Becton Dickinson recently recalled (Class 1 device correction) certain Alaris Pump Modules if they...

Experts Criticize New FDA Vaccine Skepticism Memo

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Leading vaccine experts sharply criticize a new FDA memo that claims ten children died after and because of receiving Covid-19 vac...

Positive Data in Stargardt Disease Pivotal Trial

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Belite Bio reports positive topline results from the global Phase 3 DRAGON trial of tinlarebant, marking the first successful pivo...

FDA Deploys New AI Tool Under Efficiency Scheme

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FDA says it has deployed advanced agentic AI capabilities to all agency employees, marking a major expansion of its artificial int...

Guidance to Update Manufacturing Standards for Medical Gases

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FDA posts a draft guidance outlining updated current good manufacturing practice standards for medical gases.

Glycar Recalls 1 Lot of SJM Pericardial Patch

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Glycar recalls (Class 1) certain batches of the SJM Pericardial Patch because affected units may fail to meet required tensile-str...