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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...

Higher Death Risk for Some Vibativ Patients: Reviewers

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FDA medical reviewers tell the Anti-infective Drugs Advisory Committee that Theravances Vibativ may pose a higher risk of death fo...

Phoenix Instruments Warned About QS Violations

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FDAs Chicago District Office warns Phoenix Instruments about Quality System and Medical Device Reporting violations in its facilit...

DTC Campaign Launched for Sleep Aid Intermezzo

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Transcept Pharmaceuticals says its U.S. partner, Purdue Pharmaceutical Products, is launching a $29 million national direct-to-con...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Health Technology, InControl Medical, Integra NeuroSciences, Mi Gwang Contact Le...

CDRH Lists Guidances to be Published in FY 2013

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CDRH publishes lists of guidance documents it intends to produce and hopes to produce in the current fiscal year.

Acadia Boasts Favorable Phase 3 Results in Parkinsons Trial

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Acadia Pharmaceuticals says a pivotal Phase 3 trial evaluating the efficacy, tolerability and safety of pimavanserin in patients w...

FDA Approves Cobrek Pharma Generic Luxiq Foam

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FDA approves a Cobrek Pharmaceuticals ANDA for betamethasone valerate foam 0.12%, the generic equivalent of Stiefels Luxiq Foam.

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...