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Device Compliance Official Flags Quality Gaps, Rising Enforcement
Praxis Epilepsy Drug Study Stopped for Positive Efficacy
FDA 483 Cites Apotex Over Sterility, Data Integrity Failures
Panel Votes to End Newborn Hepatitis B Shot Recommendation
Bayesian Statistical Analysis Demonstration Project
CBER Inspections Challenged by Lack of Facility Readiness
Clinical Hold Lifted on Vandas Motion Sickness Studies
Medical Device eCopy Submission Guidance

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