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FDA Medical Device Investigator Offers Insights on Inspection
FDA Medical Device Investigator Offers Insights on Inspection

Learn from Lori A. Carr's 12 years of inspecting medical device firms. Get insights on the inspection proce...

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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...