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Public Meeting on PDUFA Reauthorization

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Federal Register Notice: FDA plans a public meeting on the reauthorization of the Prescription Drug User Fee Act for fiscal years ...

Outdated Drug Monographs a Risk to Entire System: Woodcock

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CDER director Janet Woodcock tells the OTC drug industry that outdated drug monographs on which many of them rely are a risk to th...

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.

Panel to Discuss Cook Zilver-PTX Drug-Eluting Stent

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 10/13 to discuss a Cook, Inc. PMA for the Zilver-PTX drug...

FDA Seeks Reps for Tobacco Products Panel

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Federal Register Notice: FDA seeks industry organizations interested in participating in selecting non-voting industry representat...

Advocates Still Want Surgical Mesh Recalled

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Public Citizen says FDA should recall all surgical mesh products used to repair pelvic organ prolapse rather than pursue intermedi...