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CDERs Rosemary Roberts is Retiring

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CDER Counterterrorism and Emergency Coordination Staff director Rosemary Roberts announces her retirement this month.

BIO Backs Rare Disease Endpoint Pilot

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The Biotechnology Innovation Organization says FDAs new Rare Disease Endpoint Advancement Pilot Program will provide greater clari...

FDA Clears BD Alaris Pump Troubles

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FDA signs off on a Becton, Dickinson 510(k) that was filed over two years ago to update the firms troubled BD Alaris Infusion Syst...

Wuxi Pharmaceutical FDA-483

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FDA releases the form FDA-483 with one observation from an inspection at Chinas Wuxi Sta Pharmaceutical contract manufacturing org...

Abiomed Recalls All Lots of 6 Heart Pumps

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Abiomed recalls all lots of six models of its Impella heart pump due to a potential risk for impeller blade destruction.

Vir Flu Vaccine Fails Phase 2 Trial

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The Vir Biotechnology VIR-2482 investigational influenza A monoclonal antibody vaccine fails to meet the primary and secondary end...

Dismiss Norwich Rifaximin Suit: FDA

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FDA tells the DC federal court there are five reasons why it should dismiss a Norwich suit seeking to force the agency to approve ...

MediView Surgical Augmented Reality Device Cleared

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FDA clears a MediView XR 510(k) for its XR90 augmented reality-based surgical visualization and navigation platform.

Using ctDNA as an Early Endpoint

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Panelists at a Friends of Cancer Research meeting discuss the next steps to help make circulating tumor DNA available as an early ...

Bone Bolt System Cleared by FDA

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FDA clears a University of Utah Orthopedic Innovation Center 510(k) for its Bone Bolt System, an implant for percutaneous bone fra...