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High Court Seeks Guidance on Post-market Device Problem Reports

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Attorney Jill Owens says the Supreme Court may be considering hearing an appeal of a 9th Circuit decision in a Medtronic infusion ...

Court Upholds Suit Based on Company Interactions with Doc

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An Indiana appeals court rules that a state law case involving common law negligence against Medtronic can go to trial.

Drug Makers Should Re-assess Contract Testing Agreements: Attorney

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Fox Rothschild partner David Restaino recommends that drug makers reevaluate their contracts with testing laboratories and assess ...

Hepatitis C Drug Development Guidance Out

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FDA publishes a guidance on hepatitis C antiviral drug development.

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...

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 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...