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Warmer Pack Recalled Over Associated Device

[ Price : $8.95]

Medline recalls its Primary Warmer Pack because it contains the recalled Vyaire Medical enFlow Disposable Cartridge.

Panel to Discuss Chikungunya Vaccine Development

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Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to discuss chik...

Califf Airs Concerns About Zolgensma Data Lapse

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Former FDA commissioner Robert Califf says the Novartis Zolgensma data integrity case shows the need for a well-funded and staffed...

Abernathy Describes FDA IT Efforts

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FDA principal deputy commissioner Amy Abernathy tells the National Coordinator for Health IT Interoperability Forum about FDA curr...

Altaire Pharma Recalls Vet Ophthalmics

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Altaire Pharmaceuticals recalls several veterinary ophthalmic drug products due to concerns about quality assurance controls at it...

Alkem Inspection Has 4 Observations

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An FDA inspection at the Alkem Laboratories Fenton, MO, drug manufacturing facility resulted in four inspection observations.

Modernization of FDA Drug Regulatory Program Outlined

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McDermott Will & Emery attorneys outline FDA efforts to modernize the drug regulatory review process.

How to Expand RWE in Drug Decisions: Study

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The Bipartisan Policy Center, with three former FDA commissioners on its leadership team, issues a report with 12 recommendations ...

Medline Recalls Primary Warmer Pack

[ Price : $8.95]

Medline Industries recalls its Medline Primary Warmer Pack because it contains the recalled Becton Dickinson Alaris Infusion Sets ...

Edwards Recalls Sapien 3 Delivery Device

[ Price : $8.95]

Edwards Lifesciences recalls its Sapien 3 Ultra Delivery System due to balloon bursts during surgery.