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FDA Working on Guidance for Smartphone Apps

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FDA says it is developing a draft guidance to spell out when a smart phone application has crossed the regulatory threshold and ha...

FDA OKs Perrigo ANDA for Imiquimod Cream

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FDA approves Perrigo Co.s imiquimod cream, 5% a generic of Aldara cream, a treatment for actinic keratoses, superficial basal cell...

FDA Extends H.P. Acthar Gel sNDA Review

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FDA extends its review of a Questcor Pharmaceuticals supplemental NDA for H.P. Acthar Gel (repository corticotropin injection) for...

Ghosted Articles May Infest Journals: Researcher

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A Georgetown University professor says doctors, academic medical centers, and medical journals must work together to eliminate dru...

FDA Publishes Suicidality Occurrence Assessment Guidance

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FDA publishes a guidance on assessing suicidality risk in drug trials.

Judge Calls for Pay for Delay Review

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Appeals Court judge Rosemary Pooler criticizes the Second Circuit court for not rehearing a pay-for-delay suit involving Cipro.

Watson's Generic Yasmin Approved

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FDA approves a Watson Pharmaceuticals ANDA for Zarah (drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg, the generic equiva...

Spending on Rx Drugs Doubles in Decade

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A new government report says spending on prescription drugs has doubled in 10 years, accompanying a rise in multiple drug usage.

FDA Clears Viking 3D Surgery Camera System

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FDA clears a Viking Systems for its Next Generation 3DHD visualization system.

FDA Reclassifies Coronary Angioplasty Catheters

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Federal Register Final rule: FDA reclassifies standard percutaneous transluminal coronary angioplasty catheters from Class 3 to Cl...