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FDA Alert on Surgical Fire Prevention

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An FDA safety alert seeks to reduce surgical fires in operating rooms.

FDA OKs PLC Systems RenalGuard Trial

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FDA grants final approval to PLC Systems to begin a U.S. clinical trial to evaluate the efficacy of RenalGuard Therapy and RenalGu...

Panels to Discuss Isotretinoin REMS Program

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Federal Register Notice: FDAs Drug and Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees will m...

Payer Issues Seen as the Biggest Barrier to New Orphan Drugs

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Payer and reimbursement issuesnot sciencepose the greatest potential impediment to providing new therapies for patients with rare ...

FDA Extends Clinical Hold on Arikace

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FDA extends a continuing clinical hold on Insmed's Arikace (liposomal amikacin for inhalation) in patients with non-tuberculous my...

Par Sues FDA Over Off-label Restrictions

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Par Pharmaceutical files a declaratory judgment complaint and a motion for preliminary injunction against FDA over off-label restr...

Circulatory System Devices Panel to Discuss 2 PMAs

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 12/7-8 to discuss a Medtronic PMA supplement and a Cardio...

FDA Approves 'Iron Overload' Drug

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FDA approves an ApoPharma NDA Ferriprox (deferiprone) to treat thalassemia patients who've had a blood transfusion that caused iro...

WHO Calls for a Switch Away from Dental Amalgam

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In a new 61-page report, the World Health Organization calls for a switch away from use of dental amalgam because it is a signific...

Experts Tell How to Fund Rare Disease Drug R & D

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Panelists at the U.S. Conference on Rare Diseases and Orphan Products explore the role and evolution of private research foundatio...