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FDA Will Survey Healthcare Professionals on DTC Ads

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FDA describes a proposed survey of four types of healthcare prescribers for their opinions on professional and DTC ads.

Supreme Court Wont Hear OTC Case

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The Supreme Court declines to hear a case involving a state failure-to-warn suit for an OTC drug.

Markey to Introduce Compounding Pharmacy Bill

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Rep. Edward Markey says he will introduce legislation to strengthen FDA oversight of compounding pharmacies.

Still No FDA Determination on Amarin Vascepa Exclusivity

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Amarin says FDA cannot indicate when it will make a decision on the companys request that its Vascepa be declared a new chemical e...

Political Pressure Stopped Compounding Guidelines: Former FDAer

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Former FDA pharmacist Susan Sellers says that industry political pressure has kept the agency from publishing guidelines for more ...

FDA Clears Surefire Angiographic Catheters

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FDA clears a Surefire Medical 510(k) for its Surefire Angiographic Catheters for performing infusion procedures.

FDA OKs Perrigo Generic Smoking Cessation Mini Lozenges

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FDA approves a Perrigo Co. ANDA to market OTC nicotine polacrilex mini lozenge to reduce withdrawal symptoms associated with quitt...

Panel to Discuss Novo Nordisk NDAs to Treat Diabetes

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 11/8 to discuss Novo Nordisk NDAs fo...

FDA Designates Rib-X Antibiotic as QIDP

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FDA designates Rib-X Pharmaceuticals radezolid as a Qualified Infectious Disease Product for acute bacterial skin and skin structu...

USP Issues Patient-Centered Labeling Standards

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The United States Pharmacopeia publishes a universal standard on patient-centered labeling for drugs in containers dispensed by ph...