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FDA Recommends Against Using Ketoconazole in Drug Interaction Studies

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FDA recommends that drug companies and researchers avoid using oral ketoconazole in drug interaction studies due to potential live...

FDA Issues ABSSSI Drug Development Guidance

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FDA issues a guidance giving drug sponsors the agencys thinking on development programs and clinical trial designs for drugs to tr...

Advisors Reject Broader Vascepa Indication

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FDA advisory committee members recommend waiting for completion of an outcomes trial before approving a broader indication for Ama...

Furloughed FDA Employees Heading Back to Work

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House speaker John Boehner (R-OH) says there are no plans to block a Senate-brokered budget and debt limit deal and government emp...

Field Correction for GE Anesthesia System

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FDA says GE Healthcare is advising customers about a voluntary field correction for three of its anesthesia delivery systems.

FDA Approves Novo Nordisk BLA for Novoeight

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FDA approves a Novo Nordisk BLA for Novoeight (recombinant coagulation factor VIII) for use in adults and children with hemophilia...

FDA OKs Omeros Pediatric Study Plan for OMS302

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FDA approves an Omeros Corp. Pediatric Study Plan to study OMS302 (phenylephrine and ketorolac) in pediatric patients undergoing p...

FDA Issues Bacterial Endotoxins Test Guidance

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FDA issues an International Conference on Harmonization expert working group guidance on the bacterial endotoxins test general cha...

Watson Pulls Generic Wellbutrin XL 300 MG

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FDA says Watson is withdrawing its generic Wellbutrin XL 300 mg drug after tests found it was not bioequivalent to the branded dru...

Congresswoman Planning Mobile Medical App Bill

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Rep. Marsha Blackburn says she is writing legislation to give FDA more authority and resources for regulating mobile medical apps.