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QS Violations at Swedens Sonesta Medical

[ Price : $8.95]

FDA warns Solna, Sweden-based Sonesta Medical about Quality System violations in its manufacturing of three medical devices.

DHT Remote Data Acquisition Guidance

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FDA publishes a guidance with recommendations on using digital health technologies for remote data acquisition.

Animal MUMS Drug Guidance

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FDA publishes a guidance to assist sponsors in seeking approval of new animal drugs for minor uses or minor species.

CRL for Amgen Lumakras sNDA

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FDA requires an additional postmarketing confirmatory study for full approval of Amgens Lumakras non-small cell lung cancer treatm...

NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Tuesday, January 2, 2024.

FDA OKs Merck Kidney Cancer Drug

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FDA approves a Merck NDA for Welireg (belzutifan) for treating patients with advanced kidney cancer following a programmed death r...

FDA OKs Glaukos Intraocular Pressure Drug Implant

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FDA approves a Glaukos Corp. NDA for iDOSE TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for reduc...

2 Imbruvica Accelerated Approvals Withdrawn

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Federal Register notice: FDA withdraws approval of the indications for mantle cell lymphoma and marginal zone lymphoma for Pharmac...

DTC Survey Examines Quantitative Claims

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Federal Register notice: FDA sends to OMB an information collection proposal entitled A Survey on Quantitative Claims in Direct-to...

FDA Updates Breast Implant Safety Info

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FDA updates its Risks and Complications of Breast Implants Web page that clarifies information about implant removal and adds ultr...