[cem] FDA Qualified for Scientific Use

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, MPH* *Senior Methodologist, Quantitative Sciences, Flatiron Health* *Affiliate Assistant Professor, Department of Pharmacy, University of Washington*