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When the FDA Calls for an Inspection
When the FDA Calls for an Inspection

U.S. Food and Drug Administration (FDA) inspections can be nerve-wracking if an organization is unprepared....

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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...