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Guide on Drug Mfg. Discontinuance/Interruptions

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Federal Register notice: FDA makes available a draft guidance entitled Notification of a Permanent Discontinuance or Interruption ...

FDA Pulls Makena Approval Immediately

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FDA commissioner Robert Califf and chief scientist Namandj Bumpus withdraw Covis Pharmas preterm birth drug Makena and its generic...

FDA Clears restor3D 510(k) for Ankle Device

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FDA clears a restor3d 510(k) for the Axiom PSR System for use with the companys Kinos Axiom Total Ankle System.

2 Texas Men Plead Guilty to Misbranded Drug Sales

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The Justice Department says two Texas men face up to five years in prison after pleading guilty to selling misbranded drugs over t...

NADA Human Safety Assessment Guide

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Federal Register notice: FDA announces the availability of a draft guidance entitled Human User Safety (HUS) in New and Abbreviate...

Endpoint Clinical Outcome Assessment Guidance

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FDA publishes the last in a series of four guidances on aspects of patient-focused drug development.

3 Ex-Magellan Officials Charged Over Device Malfunctions

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The Justice Department charges three former top officials at Magellan Diagnostics over their role in allegedly concealing a device...

Multiple Violations in Aspire Pharma Inspection

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FDA warns Somerset, NJ-based Aspire Pharmaceuticals about multiple violations in its production of dietary supplements and human d...

Withdraw Wakix Approval: Scorpion Capital Petition

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Scorpion Capital says its research into deaths and adverse events associated with Harmony Biosciences narcolepsy drug Wakix indica...

FDA Accepts Accords Herceptin Biosimilar BLA

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FDA accepts for review an Accord BioPharma BLA for HLX02, a proposed trastuzumab (Roches Herceptin) biosimilar for treating certai...