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FDA: Pearson Education Marketing Unapproved Device

[ Price : $8.95]

FDA warns Pearson Education that it is marketing its Quotient ADHD System without clearance or approval for the intended uses.

Dramatic Increase in Essure Adverse Events: FDA

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FDA tells an advisory committee it wants an open discussion about the heightened risks vs. the benefits of Bayers Essure female pe...

Be Vigilant in Clinical Research Compliance: Attorneys

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Attorneys Julie and Andrew Rusczek offer advice on mitigating risk of fraud and abuse violations in three common clinical research...

FDA Warning Letter Close Out for Bacterin International

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FDA issues a close-out letter related to a 2013 Warning Letter issued to Belgrade, MO-based Bacterin International.

FDA Clears B. Braun Medical Infusion Pump

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B. Braun Medical gains FDA 510(k) clearance for its second-generation, large-volume Infusomat Space Pump.

FDA Accepts NDA for Glaucoma Drug

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FDA accepts for review a Bausch & Lomb and Nicox NDA for Vesneo (latanoprostene bunod ophthalmic solution 0.024%), an intraocular ...

FDA Approves Taiho NDA for Colorectal Cancer

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FDA approves a Taiho Oncology NDA for Lonsurf (trifluridine and tipiracil), a combination drug for use in patients with an advance...

FDA Grants Alcobra Fast Track for Metadoxine

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FDA grants Alcobra Ltd. fast track status metadoxine extended release for treating Fragile X Syndrome.

FDA Evaluating Tramadol-related Breathing Adverse Event

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FDA says it is investigating the pain drug tramadol and its use in children aged 17 years and younger because of a report of slowe...

Panel to Discuss Vaccines for Pregnant Women

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Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 11/13 to discuss vaccines admi...