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FDA Says Infuze MD Markets Unapproved Drugs

[ Price : $8.95]

FDA says Infuze MD is selling an unapproved cellular product.

FDA Approves Singulair Boxed Warning

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FDA approves a Boxed Warning for Singulair to strengthen awareness of potential mental health side effects.

Medical Technology Enforcement Nets $1.9 Billion

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Skadden Arps attorneys look at the six-year history of Justice Department enforcement actions against medical technology companies...

NASA Ventilator Gains Emergency Use Authorization

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FDA grants an emergency use authorization for a new high-pressure ventilator developed by NASA engineers for treating coronavirus ...

Vascular Solutions Recalls Langston Catheter

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Vascular Solutions recalls the Langston Dual Lumen Catheter due to the potential for the inner catheter to separate during use.

CME America Removing Recalled Infusion Pumps

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CME America decides to remove from the market all recalled (Class 1) BodyGuard Infusion Pump Systems because they may under or ove...

GSK Consumer Recalls 5 Lots of Benefiber Prebiotic

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FDA says GSK Consumer is recalling five lots of two Benefiber prebiotic powder products that may contain plastic pieces or shaving...

New Meeting Date for FDA Data Strategy

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Federal Register notice: FDA announces a new date, 6/30, for an earlier postponed public meeting entitled Modernizing FDAs Data St...

Bipartisan Cures 2.0 Concept Paper Out

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Reps. DeGette and Upton release a bipartisan concept paper on Cures 2.0 with eight items that FDA would be expected to do.

Workshop on Generic Regulatory Science Initiatives

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Federal Register notice: FDA announces that a 5/4 public workshop entitled FY2020 Generic Drug Regulatory Science Initiatives is b...