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No IND Submitted for Study

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FDA warns San Francisco, CA-based dentist Pamela Den Besten about conducting a clinical trial on an investigational drug without a...

Multiple Violations at Persōn & Covey

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FDA warns Glendale, CA-based Persōn & Covey about CGMP violations in its production of unapproved drugs.

CDER Head Targets Surrogate Endpoints, Lupus Drug

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In an unprecedented LinkedIn post, CDER director George Tidmarsh questions the use of surrogate endpoints and publicly attacks Aur...

Quantitative Medicine CoE Progress Update

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The CDER Quantitative Medicine Center of Excellence issues a report on goals and accomplishments in the first 16 months of its exi...

Sharp Reductions in FDA Operations Under Shutdown: HHS

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An HHS contingency plan says FDA would experience sharp reductions in operations if Congress fails to reach a deal to fund the gov...

FDA Approves New Zoll Monitor/Defibrillator

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FDA approves a Zoll Medical PMA for Zenix, the companys newest monitor/defibrillator, which the company says is designed to stream...

OND Custom Medical Queries Are Useful: Article

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FDA researchers say the OND Custom Medical Queries developed to improve the identification and analysis of new drug safety signals...

New Guidance on Adaptive Clinical Trial Designs

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FDA posts an International Council for Harmonization draft guideline entitled E20 Adaptive Designs for Clinical Trials that provid...

CDRH Expands Recall of BD Alaris Pump Infusion Sets

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FDA issues an updated alert about an ongoing Class 1 recall of certain BD Alaris Pump Module infusion sets due to device performan...

FDA Protected From Firings During Shutdown: Makary

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FDA commissioner Marty Makary tells agency employees that they are protected from planned mass workforce firings if a government s...