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Device Compliance Official Flags Quality Gaps, Rising Enforcement
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FDA 483 Cites Apotex Over Sterility, Data Integrity Failures
Praxis Epilepsy Drug Study Stopped for Positive Efficacy
Breyanzi OKd for Hard-to-Treat Marginal Zone Lymphoma
FDA Advisers Reject J&Js V-Wave Heart Shunt
Bayesian Statistical Analysis Demonstration Project
CBER Inspections Challenged by Lack of Facility Readiness

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