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FDA Clears Esaote Laptop-Sized Ultrasound

[ Price : $8.95]

FDA clears Esaote North Americas MyLab Gamma portable laptop-sized ultrasound system.

Guidance on Cybersecurity in Devices

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Federal Register Notice: FDA releases a guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devi...

FDA OKs B. Braun Bulk Sterile Water for Compounding

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FDA approves B. Braun Medicals Sterile Water for Injection USP in 2L and 3L containers for compounding devices.

EMA Runs Past FDA on Clinical Trial Transparency Front

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The European Medicines Agency moves ahead of FDA in terms of clinical trial data transparency with its 10/2 decision to publish th...

IDE Review Procedure Issued

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CDRH issues a standard operating procedure for reviewing IDE application-specific issues.

FDA Allows NY Fertility Institute to Resume Operations

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CBER says New York Fertility Institute has achieved compliance with regulations and can resume full manufacturing of HCT/Ps.

CGMP Problems at Hospira Australia

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FDA warns Hospira Australia about CGMP violations at its Victoria drug manufacturing plant.

Researchers Develop New Drug Capsule

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Researchers say they have developed a drug capsule that uses needles to deliver a biologic directly to the stomach lining and keep...

FDA to Release Device Cybersecurity Guidance

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FDA says it will publish a final guidance for medical device manufacturers on promoting cybersecurity in their products.

Zogenix Files sNDA for Abuse-deterrent Form of Zohydro ER

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Zogenix files a supplemental NDA for a reformulated version of its controversial pain drug Zohydro ER (hydrocodone bitartrate) ext...