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Vanda Blasts FDA Plan to Lengthen Drug Review Times

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Vanda Pharmaceuticals says FDA should withdraw a legislative proposal in its budget package that the company says would lengthen N...

FDA, Device Industry Reach Agreement on MDUFA VI

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FDA and the device industry are nearing a final agreement on the next round of Medical Device User Fee Act (MDUFA VI) negotiations...

Medline Class 1 Recall of Angiographic Control Syringes

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Medline Industries recalls (Class 1) its angiographic control syringes, warning the devices could cause severe injury or death.

FDA Budget Proposal Signals Push for Tighter Ad Oversight

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Law firm Sheppard breaks down some of FDAs proposals in its budget documents that industry should keep a close eye on, including n...

Workshop on Novel Surrogate Endpoints for Rare Disease Drugs

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FDA announces a 5/18 virtual public workshop aimed at advancing the use of novel surrogate endpoints in developing treatments for ...

Insmed Halts Brensocatib Program After Mid-Stage Trial Miss

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Insmed discontinues development of its drug candidate brensocatib for hidradenitis suppurativa after a mid-stage clinical trial fa...

See Supply Chain Strategy as Core Regulatory Function: Attorney

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Baker Hostetler attorney Winston Kirton says life sciences companies that are active in both the U.S. and the EU need to change th...

FDA Not Keeping Pace with Non-Oncology Basket Trials: Column

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A Clinical Trial Vanguard online column explains how a 2022 FDA master protocol guidance has not kept pace with non-oncology baske...

FDA Lifts Partial Clinical Hold on MacroGenics Cancer Study

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FDA removes partial clinical hold against MacroGenics Phase 2 LINNET study evaluating the investigational cancer therapy lorigerli...

Mass Compounding Threatens FDA Enforcement: Column

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An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage.