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FDA Extends Review of BMS CAR T-cell Therapy

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FDA extends by three months its review of a Bristol Myers Squibb BLA for lisocabtagene maraleucel for treating adults with relapse...

FDA Approves Novartis Lung Cancer Drug

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FDA approves a Novartis Pharmaceuticals NDA for Tabrecta (capmatinib) for treating certain adult patients with non-small cell lung...

HeadsafeIPs Brain Assessment Device Cleared

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FDA clears a HeadsafeIP 510(k) for its Nurochek system for brain assessment in patients aged 14 years and older.

Praise, Suggestions for Enhanced Purple Book

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Two drug industry associations praise FDA for improving the Purple Book and suggest further enhancements.

Is FDAs Credibility at Risk from Pandemic Actions?

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An in-depth McClatchy News article explores the fears of some public health officials that FDAs haste to authorize some tests and ...

TherapeuticsMD Wants Imvexxy ANDA Restrictions

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TherapeuticsMD asks FDA to issue product-specific guidance putting restrictions on applications for a generic form of Imvexxy.

Alarming Trend in Schizophrenia Drug Trials

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Former FDAer Thomas Laughren says improved patient selection for schizophrenia drug clinical trials could reduce the problem of in...

Device Discontinuance Notification Guidance

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FDA issues an immediately-in-effect guidance relating to the new requirement for medical device manufacturers to notify FDA about ...

QS Violations at Bedfont Scientific

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FDA warns Englands Bedfont Scientific about Quality System violations in its manufacturing of carbon monoxide gas analyzers.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Bedfont Scientific, Philosys and Shriram Institute for Industrial R...