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FDA Approves Impax/Tolmar Generic Solaraze

[ Price : $8.95]

FDA approves an Impax Laboratories and Tolmar ANDA for a generic version of PharmaDerms Solaraze Gel (diclofenac sodium-3%), indic...

Brovana Brochures Have Multiple Violations, OPDP Says

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says patient brochures for Sunovions Brovana make unsubstantiated efficacy claims and ...

FDA Wants to Study Adolescents Reactions to DTC Drug Ads

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FDA solicits comment on a plan to research how adolescents respond to risk and benefit information in DTC drug ads marketed to the...

FDA Grants Pharmalink an Orphan Drug Designation

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FDA grants Pharmalink an orphan drug designation for Busulipo, a conditioning agent for use in cancer patients prior to hematopoie...

QS Violations in King Systems Inspection

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FDAs Detroit District Office warns King Systems about Quality System Regulation violations in its manufacturing of breathing circu...

Hepatitis C Drug Development Guidance Out

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FDA issues a draft guidance to help sponsors plan clinical development of direct-acting antiviral drugs for treating hepatitis C.

FDA Approves Afaxys Generic Contraceptive

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FDA approves an Afaxys Pharmaceuticals ANDA for contraceptive Aubra (levonorgestrel and ethinyl estradiol tablets, USP 0.1mg/0.02m...

Court Reasoning Flawed in Infuse Preemption Case: Attorney

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Attorney Matthew Reed says an Arizona federal court contradicted itself in ruling that a state law claim against Medtronics Infuse...

FDA Clears iTraumaCare Expanded Indication

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FDA clears an iTraumaCare expanded indication for its iTClamp Hemorrhage Control System to include the temporary control of severe...

Nominations Sought for Tobacco Panel

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Federal Register Notice: FDA seeks nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee.