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CDER Denies Petition Seeking Reformulated ADHD Drugs

[ Price : $8.95]

CDER denies a 2006 citizen petition from physician John C. Kulli that requested it issue a regulation requiring attention deficit ...

FDA Approves New Test for Detecting Yeast Pathogens

[ Price : $8.95]

FDA approves a de novo petition to allow the marketing of T2 Biosystems direct blood test for detecting five yeast pathogens that ...

FDA Breakthrough Designation for Eylea in Diabetic Retinopathy

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FDA grants Regeneron Pharmaceuticals a breakthrough therapy designation for Eylea injection for treating diabetic retinopathy in p...

OPDP Cites Cipher Pharma Over e-Pharm Emails

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CDERs Office of Prescription Drug Promotion objects to a Cipher Pharmaceuticals e-Pharm/alert email for Lipofen (fenofibrate capsu...

Bill to Free REMS-blocked Drug Samples for Generics

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A new House bill aims to close a loophole that is used by some brand drug makers to prevent potential generic drug firms from obta...

OIG Advisory on Drug Copayment Coupons

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A special advisory bulletin from HHS Office of Inspector General raises concerns on the measures used by pharmaceutical manufactur...

Orphan Status for Navidea Drug in Head, Neck Cancer

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FDA grants orphan drug status to Navidea Biopharmaceuticals for Lymphoseek Injection for sentinel lymph node detection in head and...

FDA Sets User Fee Goal for Salix Irritable Bowel Drug

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FDA assigns a user fee goal date for Salix Pharmaceuticals sNDA for Xifaxan for treating irritable bowel syndrome with diarrhea.

FDA Urged to Act on Ranbaxy Nexium ANDA

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Consumer advocates say FDA should either find that a Ranbaxy ANDA for generic Nexium is ready for immediate approval and market en...

FDA Awards Critical Path Institute $2.1 Mil

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FDA awards the Critical Path Institute a second five-year grant that could total $10.5 million.