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FDA Clears ArtVentive Medical Occlusion System

[ Price : $8.95]

FDA clears an ArtVentive Medical Group 510(k) for its Endoluminal Occlusion System that is intended for use in the peripheral vasc...

Incytes Jakafi sNDA Approved for Bone Marrow Disease

[ Price : $8.95]

FDA approves an Incyte Corp. supplemental NDA for Jakafi (ruxolitinib) for treating patients with polycythemia vera, a chronic typ...

FDA Clears Fiagon AG Navigation Extended Instrument Set

[ Price : $8.95]

FDA clears a Fiagon AG 510(k) for its ear, nose and throat Extended Instrument Set.

Ebola Priority Review Voucher Bill Goes to House

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The Senate approves unanimously legislation adding Ebola as a qualifying disease for the FDA priority review voucher program.

FDAers Push Random Ebola Therapy Trials

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Three FDAers make the case for randomized, controlled trials rather than an historical control in evaluating potential Ebola thera...

Find Better Provider Education for REMS: McKesson

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Stakeholders call on FDA to look for new ways to educate healthcare providers about REMS.

FDA Pregnancy and Lactation Labeling Rule

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FDA issues a final rule and draft guidance on drug and biological product labeling for pregnancy and lactation information.

Hamburg on Female Representation in Clinical Trials

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FDA commissioner Margaret Hamburg discusses the improving representation of women in clinical trials.

FDA OKs PulmoFlow Drug/Device Combo for Cystic Fibrosis

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FDA approves a PulmoFlow NDA for Kitabis Pak a co-packaging of tobramycin inhalation solution with a Pari LC Plus Nebulizer for t...

Indian Drug Companies Fudge Test Results: News Service

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Bloomberg News reports that FDA documents show that many Indian drug manufacturers routinely delete test results showing potential...