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Few ODAC Advisory Committee Questions Difficult: Study

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University researchers say they found relatively few instances in which Oncology Drugs Advisory Committee members reported difficu...

FDA SSDC White Paper Out

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CDER issues a white paper tracing the history of selective safety data collection (SSDC) and plans for the future.

FDA Extends Review of GSK Multiple Myeloma BLA

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FDA extends by three months its review of a GSK BLA for Blenrep (belantamab mafodotin) combinations for treating patients with rel...

Longer Drug Review Time Means Fewer Approvals: CBO

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Responding to congressional Democrats, the Congressional Budget Office says a nine-month increase in FDA drug review times would l...

FDA Alert on Baxters Infusion Pump

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FDA issues an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume infusion pump.

Official Action Indicated Rare in GCP Inspections: Report

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FDA researchers analyze the results of good clinical practice inspections from 2017 to 2023, finding that less than 1% resulted in...

FDA: Multiple Violations at O3UV

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FDA warns Grand Ledge, MI-based O3UV about multiple CGMP violations in its illegal production of autohemotherapy devices.

CGMP Violations at Glenmark Unit

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FDA warns Indias Glenmark Pharmaceuticals about CGMP violations in the production of finished drugs at one of its manufacturing fa...

FDA Rejects Replimune BLA for Melanoma Therapy

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FDA rejects a Replimune priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec).

FDA Wins as Sarepta Folds and Stops Shipping Elevidys

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FDA wins the latest round in its regulatory battle against gene therapy maker Sarepta Therapeutics after the company agrees to sto...