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Sklamberg to Head CDER Office of Compliance

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CDER director Janet Woodcock says Howard Sklamberg will become director of the Centers Office of Compliance early next year.

Endo Urges Quick Action on Opana ER Withdrawal Petition

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Endo asks FDA to act quickly in determining that its non-crush resistant Opana ER was withdrawn from the market for reasons of saf...

Forest Labs Files NDA for Schizophrenia/Bipolar Drug

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Forest Laboratories submits an NDA for cariprazine, indicated for treating schizophrenia and manic or mixed episodes associated wi...

FDA Denies Request Seeking Stronger Warnings on Amitiza

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FDA rejects a Public Citizen petition seeking a boxed warning and other changes to labeling for Sucampo and Takedas constipation d...

InControl Medical Inspection Found Multiple QS Violations

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FDAs Minneapolis District Office warns InCentral Medical about Quality System violations in its manufacturing of the InTone female...

FDA OKs IND for Ulcerative Colitis Candidate

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FDA approves an Avaxia Biologics IND for AVX-470 for treating of ulcerative colitis.

Doryx Reformulations May be Anti-competitive: FTC

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The Federal Trade Commission supports Mylans lawsuit contending that Warner Chilcott used product reformulations to delay market e...

FDA Clears AtCor Medical Blood Pressure Device

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FDA clears an AtCor Medical 510(k) for its SphygmoCor XCEL device, a new blood pressure cuff-based system that allows brachial and...

Quality, Reporting Problems Found at Nexera

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FDAs Florida District Office warns Nexera Medical about Quality System and Medical Device Reporting violations in its manufacturin...

DTC Ads Improve Consumer Welfare: Study

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Health economist Jayani Jayawardhana says her research shows that drug DTC ads help improve consumer welfare by promoting treatmen...