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Serious Sterile Drug Deficiencies at Johnson Memorial

[ Price : $8.95]

FDAs New England District Office warns Johnson Memorial Cancer Center about serious deficiencies in its production of sterile drug...

FDA: Company Distributing 5 Unapproved New Drugs

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FDAs Los Angeles District Office warns Biomedic Labs that it is distributing unapproved new drugs through two Web sites.

Califf Praises FDA Staff

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FDA commissioner nominee Robert Califf praises the intensity of mission and dedication of the agency staff during a conference app...

FDA Accepts Revision Optics PMA for Vision Inlay

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FDA accepts for review a ReVision Optics PMA for the Raindrop Near Vision Inlay, a microscopic hydrogel inlay designed to correct ...

Law Firm Touts Preemption Court Win

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Kaye Scholer says an Illinois federal judge ruled that multi-district litigation testosterone replacement therapy claims against A...

FDA Wants Better Funding Predictability in Next PDUFA

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FDA says the next Prescription Drug User Fee Act program should have better funding predictability.

FDA OKs Genentechs Cotellic for Melanoma

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FDA approves a Genentech NDA for Cotellic (cobimetinib) and its use in combination with the companys Zelboraf (vemurafenib) to tre...

Interventional Spine Next-gen Opticage Spinal Device Cleared

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FDA clears an Interventional Spine 510(k) for its Opticage Expandable Interbody Fusion Device, an enhanced version of its 2012-cle...

WLF Wants High Court to Hear OTC Preemption Case

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Washington Legal Foundation and the Allied Educational Foundation urge the Supreme Court to hear an OTC ibuprofen labeling case to...

MDUFA 4 Stakeholders Want More Diverse Trials

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Stakeholders meeting with FDA on MDUFA 4 reauthorization say there should be more population diversity in medical device clinical ...