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FDA General

Government Not Using Park Doctrine Enough: Study

Harvard Medical School researchers call for a reinvigoration of the Park doctrine holding corporate officers personally liable for misconduct by drug ...

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Human Drugs

BioLab Sciences Illegally Selling Products: FDA

FDA warns Scottsdale, AZ-based BioLab Sciences it is illegally marketing drug and biologic products that have been produced with significant CGMP viol...

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Human Drugs

FDA Reviewers Question Spectrums Pozenveo

FDA medical reviewers tell the Oncologic Drugs Advisory Committee there are significant questions about Spectrum Pharmaceuticals proposed lung cancer ...

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Human Drugs

Agency Questions Confirmatory Study for Pepaxto

FDA reviewers say that a confirmatory trial has not confirmed the clinical benefit of Oncopeptides Pepaxto (melphalan flufenamide), throwing into ques...

Human Drugs

Comments on FDA Draft RTOR Guidance

The Alliance for Regenerative Medicine and Pfizer suggest changes to an FDA draft guidance on real-time oncology review.

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Human Drugs

Year-One Report on the Generic Drug Cluster

CDER Office of Generic Drugs associate director Sarah Ibrahim discusses the first-year output of the new Generic Drug Cluster involving several regula...

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Medical Devices

Cybersecurity Alert on Medtronic MiniMed Pump

FDA issues a safety alert on a cybersecurity risk with Medtronics MiniMed 600 Series Insulin Pump System (e.g., MiniMed 630G and MiniMed 670G).

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Federal Register

FDA Seeks Patient Advocates for Regulatory Forum

Federal Register notice: FDA seeks patient advocate applications to participate under its collaboration with the Clinical Trials Transformation Initia...

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Federal Register

Roches Endep Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Hoffmann-La Roches Endep (amitriptyline HCl) was not withdrawn from sale for safety or effectiveness reas...

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Medical Devices

FDA Clears New Roche cobas Diagnostic Platform

Roche gains FDA 510(k) clearance for the cobas pure integrated solutions, the next generation of its cobas diagnostics platform.