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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

[ 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

[ Price : $8.95]

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...

House OKs Rare Pediatric Disease Voucher Program

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The House approves legislation reauthorizing the FDA Pediatric Rare Disease Priority Review Voucher program and giving the agency ...

Monoclonal Antibody Streamlined Safety Study Guidance

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FDA publishes a draft guidance on streamlined nonclinical safety studies for monoclonal antibodies.

FDA Safety Alert on Some BD Alaris Pump Modules

[ Price : $8.95]

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