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Orphan Drugs Info Collection Revision

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision for Orphan Drugs; 21 CFR Part 316.

Class 1 Recall of Alaris Pump Module

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FDA classifies as Class 1 a recall of Becton Dickinsons Alaris Pump Module and Pump Module Door Assembly Replacement Kits because ...

Guide on Bladder Cancer Drug Development

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Federal Register notice: FDA makes available a draft guidance entitled Bladder Cancer: Developing Drugs and Biologics for Adjuvant...

Voluntary Device Malfunction Summary Program Updated

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FDA updates its information Web page about eligibility for its Voluntary Malfunction Summary Reporting program.

Mesoblast BLA Gets Complete Response Letter for Remestemcel-L

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FDA issues Mesoblast a complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft...

Guide on Renal Cell Carcinoma Drug Development

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Federal Register notice: FDA makes available a draft guidance entitled Renal Cell Carcinoma: Developing Drugs and Biologics for Ad...

BMS Opdivo-Yervoy Combo for Mesothelioma

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FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for first-line treatment of adults w...

Trump Given Investigational Regeneron Covid-19 Cocktail

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President Trump begins taking an investigational drug cocktail from Regeneron after being confirmed to be infected with Covid-19.

FDA Renews, Expands Certara Software

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FDA renews and expands its use of Certara biosimulation software in 11 agency divisions and offices.

Opioid Disorder Effectiveness Endpoint Guidance

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FDA issues a guidance on clinical endpoints to demonstrate the effectiveness of drugs indicated to treat opioid use disorder.