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Hearing on Internet, Social Media Promos

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Federal Register Notice: FDA will hold a public hearing 11/12-13 in Washington, DC on issues related to promoting FDA-regulated pr...

Valeant/Glaxo Plan NDA for Epilepsy Drug

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Valeant Pharmaceuticals and GlaxoSmith Kline plan an NDA submission for retigabine, a neuronal potassium channel opener for adult ...

Smiths Medical Recalls Pediatric Tracheal Tubes

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Smiths Medical ASD recalls (Class 1) its Portex Uncuffed Pediatric Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0, and 3.5 mm).

Hamburgs Daunting Mission: Raising Public Respect for FDA

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FDA Webview editor Jim Dickinson analyzes commissioner Margaret Hamburgs daunting top priority rebuilding public trust and finds...

FDA Accepts ANDAs for Original Zosyn, Approves Orchids

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FDA approves Orchids ANDA for a generic version of Wyeths original intensive-care antibiotic, Zosyn

Arena Reports Positive Lorcaserin Trial Results

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Arena says it will submit a December NDA to FDA for its weight management drug lorcaserin.

FDA Reviewing BSD Medical HDE on Cancer System

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BSD Medical says FDA is continuing its review of a humanitarian device exemption (HDE) submission for the BSD-2000 Hyperthermia Sy...

Hatch and Waxman Spar Over Health Issues at GPhA

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Orrin Hatch and Henry Waxman, co-sponsors of the 1984 legislation that created the modern generic pharmaceutical industry, spar ov...

FDA OKs Novartis Combo Pill for Hypertension

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FDA approves Novartis Valturna (aliskiren and valsartan) tablets for treating high blood pressure.