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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...

Dr. Reddys Needs Third-party Auditor, CEO Says

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Dr. Reddys Laboratories says FDA has directed it to hire a third-party auditor to evaluate its three Indian manufacturing plants t...

FDA Hits LDT Firms for DTC Tests Without Clearance

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FDA sends three laboratory-developed test makers letters challenging their genetic tests being marketed to consumers without agenc...