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Bill Would Change FDA Expanded Access Program

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Rep. Michael McCaul introduces legislation to reform FDAs compassionate use policy.

Alere Corrects Testing System for Monitoring Warfarin Therapy

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Alere Inc. begins a voluntary correction to inform U.S. users of the Alere INRatio and INRatio 2 PT/INR Monitor system about certa...

FDA Clears CenterVue 510(k) for Confocal Scanner

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FDA clears a CenterVue 510(k) for its Eidon color confocal scanner, an automated retinal imaging system that combines confocal sca...

Critically Examine FDA Engagement Processes: MS Society

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Stakeholders urge FDA to continue to look for better ways to engage patients in providing information to the agency for use in pro...

FDA Accepts NDA from Aprecia Pharma Using Novel Delivery Formulation

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FDA accepts for filing an Aprecia Pharmaceuticals NDA for the first product using its proprietary ZipDose technology.

QS Problems Found in US Infusion Inspection

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FDAs Florida District Office warns US Infusion, Inc., about multiple Quality System Regulation violations in its work as a specifi...

Guidance on Rx Drug Distributor Annual Reporting

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Federal Register Notice: FDA releases a draft guidance: Drug Supply Chain Security Act Implementation: Annual Reporting by Prescri...

Panel to Discuss Ferring NDA to Treat Nocturia

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 1/12/15 to discuss a Ferring Pharma ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Autopista, Fioravanti Custom Products, LLC dba Essential Wholesale & Labs US Inf...

Appeals Court Upholds Dismissal of Enbrel Biosimilar Challenge

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The Federal Circuit Court Of Appeals upholds a lower court ruling that found it premature for Sandoz to obtain a declaratory judgm...