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Panel Backs Drug-eluting Stents

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An FDA advisory committee says the benefits outweigh the risks of blood clots associated with drug-eluting stents.

Panel to Discuss Depressive Disorder Device

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Federal Register Notice: FDAs Neurological Devices Panel will meet 1/26 to discuss a PMA for a device to treat major depressive di...

King Introduces New Bicillin L-A

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FDA says King has launched a revised Bicillin L-A, which had been in short supply and for emergency use only.

Gottlieb Says He Wasnt Criticizing FDA on RiskMAPs

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FDA deputy commissioner for medical and scientific affairs Scott Gottlieb says his concerns about expanding RiskMAPs, reported yes...

Latest EIRs, FDA-483s Received from FDA

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FDA Webview posts to its site the latest FDA-483s, EIRs and related correspondence received from FDA for Cardinal Health, Hitachi ...

Von Es Nomination Gains Steam with Frist Cloture Petition

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Senate leader Bill Frist (R-TN) files a cloture petition seeking to remove the holds on acting commissioner Andrew von Eschenbachs...

GSK Opens RAISE Eltrombopag Trial

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GSK opens a long-term trial of its investigational eltrombopag for previously-treated patients with chronic idiopathic thrombocyto...

Companies Want ICH Pharmacopeia Agreement

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Comments on a draft harmonization guidance say any of the three signatory pharmacopeias should not be able to say they have harmon...

FDA OKs Alimeras OTC Eye Itch Drops

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FDA approves an Alimera Sciences Inc. NDA for Alaway, an OTC eye allergy treatment for itch eyes.

Ethical Issues Have FDA in a Dilemma

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Consulting editor John Scharmann reviews ethical issues surrounding FDA advisory advisory committees and concludes its time to bit...