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Katelyn Weed

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Posted by Katelyn Weed on Tue, Jul 16, 2019

2018 FDA Warning Letters: Common Deficiencies

Each year, the FDA publishes its Bioresearch Monitoring (BIMO) metric findings to provide insight on audit trends and significant violations. The BIMO program’s inspectional data includes Clinical Investigative Sites, Institutional Review Boards (IRBs), Sponsors/Monitors, Contract Research Organizations CROs), Bioequivalence, and Good Laboratory Practice Audits.

Topics: BIMO Metrics, FDA Warning Letters

Posted by Katelyn Weed on Thu, Jul 11, 2019

FDA Inspections: Findings for Clinical Investigators

As we have done in past years, IMARC examined the warning letters posted on the FDA’s website to compile the top findings from BIMO inspections. This year, we are reflecting on the top findings of previous years and discussing trends seen in 2018.

Topics: FDA Warning Letters, BIMO Program, FDA Inspections

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