Associate Director for Research at the Office of Biostatistics & Epidemiology, in the Center for Biologics Evaluation and Research. He arranged for the FDA to do this evaluation of CEM. They then evaluated the software, quizzed us about various features and processes, and they made their decision.
Hello,
I'm very interested in using CEM for some projects evaluating oncology therapies, some of which may be submitted to the FDA. Could someone provide more context regarding the note on the CEM website that CEM has officially been "Qualified for Scientific Use" by the U.S. Food and Drug Administration as I've not seen this designation used before? I'm particularly interested in understanding what criteria the FDA used in granting this designation and, if applicable, which group within the FDA (e.g. CDER, CBER, CDRH) granted it.
Thanks!Carrie--
Carrie Bennette, PhD, MPHSenior Methodologist, Quantitative Sciences, Flatiron HealthAffiliate Assistant Professor, Department of Pharmacy, University of Washington