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Soulaire Marketing Unapproved Device: FDA

[ Price : $8.95]

FDA warns Soulaire Corp. that it is marketing an external counterpulsation system for unapproved uses, adulterating and misbrandin...

2 CGMP Violations in Natco Pharma Inspection

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FDA warns the Telangana, India-based Natco Pharma manufacturing facility about CGMP violations in its production of finished drugs...

Clinical Trial Innovation Center Established

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CDER establishes the Center for Clinical Trial Innovation to support innovative approaches to clinical trials that are designed to...

Ex-CEO Sentenced Over Phony Covid Test

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A federal court sentences former Decision Diagnostics CEO Keith Berman to seven years in prison for a securities fraud scheme invo...

FDA Warns on Suspected Counterfeit Botox

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FDA issues a safety alert on unsafe counterfeit versions of AbbVies Botox (botulinum toxin) have been found in multiple states and...

Xstim Spine Fusion Stimulator Approved

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FDA approves an Xstim PMA for the Xstim Spine Fusion Stimulator for bone growth stimulation.

CBER Joining Lupus Research Consortium

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FDA adds CBER to its partnership with the Lupus Accelerating Breakthroughs Consortium to better focus on engineered cell therapies...

C&T Dream Co. CGMP Violations

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FDA warns South Koreas C&T Dream Co. about CGMP violations in its manufacturing of finished drugs.

New CDRH Dataset for Chemical Characterization

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FDA launches a new public dataset to help chemistry labs ensure the robustness of chemical characterization methods used to assess...

GSK BLA Accepted for Meningococcal Vaccine

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FDA accepts for review a GSK BLA for its 5-in-1 meningococcal ABCWY vaccine candidate.