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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites American Quality Manufacturing, John Caton, Jr., M.D., For Earth, Lonza Biologic...

CGMP Violations Found at Lonza Biologics

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FDAs New England District Office warns Lonza Biologics about CGMP violations in its manufacture of finished pharmaceuticals and ac...

Luitpold Warned About CGMP Problems

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FDAs New York District Office warns Luitpold Pharmaceuticals about CGMP violations at its drug manufacturing facility.

Advanced Bionics Reintroducing Troubled Cochlear Implant

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Advanced Bionics gains FDA approval to reintroduce into the market its HiRes 90K cochlear implant that was recalled last year due ...

FDA Should Tighten Approval Standards on Transplant Drugs: Editorial

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A medical journal editorial calls on FDA to tighten its approval criteria for generic immunosuppressive drugs.

FDA Panel Backs Label Change for Bisphosphonates

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FDA advisory committee members vote to recommend that the labeling on osteoporosis-treating bisphosphonates state just how long pa...

CDER Adds a Review Division Under Oncology Reorganization

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CDER reorganizes its Office of Oncology Drug Products, adding an extra review division, and realigning review divisions by experti...

Triad Faces Another Lawsuit on Contaminated Wipes

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Triad Group's legal troubles mount as another lawsuit is filed against the company and sister company H&P Industries over allegedl...

FDA Clears WideMed Sleep Monitor

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FDA clears a WideMed 510(k) for its home sleep monitoring device, Morpheus Ox, intended for use in the cardiac patient population.

Medtronic Recalls Drug Pump

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Medtronic and FDA warn healthcare professionals about a Class 1 recall involving the SynchroMed II Infusion system.