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FDA issues a draft guidance to help sponsors plan clinical development of direct-acting antiviral drugs for treating hepatitis C.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

FDA Approves Alere Determine HIV Test

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FDA approves an Alere PMA for its Alere Determine HIV-1/2 Ag/Ab Combo test, a rapid point-of-care test that detects both HIV-1/2 a...

Report Describes FDAs Personalized Medicine Efforts

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FDA issues a report on its work to advance personalized medicine.

Coalition Advances More Ways to Foster Combination Products

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The Combination Products Coalition gives FDA additional recommendations on ways to speed guidance to encourage development of inno...