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BioLab Sciences Illegally Selling Products: FDA

[ Price : $8.95]

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

FDA Reviewers Question Spectrums Pozenveo

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

Agency Questions Confirmatory Study for Pepaxto

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

Comments on FDA Draft RTOR Guidance

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The Alliance for Regenerative Medicine and Pfizer suggest changes to an FDA draft guidance on real-time oncology review.

Year-One Report on the Generic Drug Cluster

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

Cybersecurity Alert on Medtronic MiniMed Pump

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

FDA Seeks Patient Advocates for Regulatory Forum

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

Roches Endep Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Hoffmann-La Roches Endep (amitriptyline HCl) was not withdrawn from sale for safety o...

FDA Clears New Roche cobas Diagnostic Platform

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

ClearPoint Neuro Navigation Software Cleared

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FDA clears a ClearPoint Neuro 510(k) for its version 2.1 of the ClearPoint Neuro Navigation software.