National Cancer Institute (NCI)November 15, 2016

FDA 483 - National Cancer Institute (NCI) - November 15, 2016

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Record Details

An FDA inspection of the National Cancer Institute (NCI) in Rockville, MD, identified a significant failure in their role as a clinical trial sponsor. The inspection revealed that NCI did not properly monitor a study or ensure adherence to the protocol, specifically regarding the timely reporting of serious adverse events. This indicates a lapse in oversight for clinical trial conduct.

Company: National Cancer Institute (NCI)
Inspection Date: November 15, 2016
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East II
People: David Chen (company_representative)
Quynh-Van Tran
John Dan (investigator)

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ID · 6147d136-d50e-46bd-a9e1-7e7869a30f56