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FDA Guidance for Clinical Investigators, Sponsors and IRBs Regarding Adverse Event Reporting in GCP Regulated Environments
FDA Guidance for Clinical Investigators, Sponsors and IRBs Regarding Adverse Event Reporting in GCP Regulated Environments

This white paper examines the key points of the guidance and the thinking behind the FDA’s 2009 “Guidance f...

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Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments
Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments

How an enterprise quality management system (EQMS) can help you avoid 483 observations during your next fac...