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Tripartite Meeting Looks at Antibacterial Regulation

[ Price : $8.95]

Representatives from FDA, the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency are working on...

Equipment Contamination Seen in 2 Aurobindo Inspections

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Indias The News Minute says FDA inspections at two Aurobindo drug manufacturing facilities raised concerns about equipment contami...

Conformis Hip System Cleared

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FDA clears a Conformis 510(k) for its Conformis Hip System.

FDA Needs AI Standards: Executive

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Charles Fisher, who founded an artificial intelligence company that works in drug clinical trials, urges FDA to develop a framewor...

FDA in 2 Collaborative Communities

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CDRHer Michelle Tarver says FDA is participating in two collaborative communities and wants to be in 10 by the end of 2020.

FDA Clears Dx 360 Rotatable Disposable Sheath

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FDA clears a UVision360 510(k) for the 3mm Luminelle Dx 360 Rotatable Disposable Sheath, an attachment for the Luminelle DTx Hyste...

Put Tramadol in High CSA Classification: Public Citizen

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Public Citizen petitions FDA and the Drug Enforcement Administration to up-classify Tramadol and similar drugs from Schedule 4 to ...

CBER Regulatory Meeting SOPP

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CBER issues a SOPP on regulatory meetings under some user fee programs.

GSK Asks FDA Review of Zofran Information

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GlaxoSmithKline asks FDA to look at four categories of information that have been raised in litigation over Zofran pregnancy label...

Vyaire Medical Gains Ventilator Clearance

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FDA clears a Vyaire Medical 510(k) for the bellavista 1000e ventilator.