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FDA Alert on Olympus Ligating Device Instructions

[ Price : $8.95]

FDA issues a device correction alert after Olympus recalled (Class 1) the instructions for its Single Use Ligating Device PolyLoop...

The Case for FDA Advisory Committees: Column

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provals managing director Steven Cohen lists the many benefits of FDA advisory committees even as the agency has reduced its use o...

Turalio Video Testimonial False or Misleading: OPDP

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The CDER Office of Prescription Drug Promotion says a Daiichi Sankyo promotional video patient testimonial for its Turalio mislead...

Rhyz Analytical Labs CGMP Violations

[ Price : $8.95]

FDA warns Provo, UT-based Rhyz Analytical Labs about CGMP violations in its work as a contract testing laboratory.

Multiple Turbare Manufacturing Violations

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FDA warns Conway, AR-based Turbare Manufacturing about CGMP and other violations in its work as an outsourcing facility producing ...

QTc Information Labeling Guidance

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FDA publishes a guidance to assist applicants in incorporating heart rate-corrected (QTc) interval of prolongation-related informa...

Judge Strikes Down FDA Decision Blocking Priority Voucher

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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...