ASCO Submits Comment Letters to the FDA on Modernizing Clinical Trials

November 6, 2018 – ASCO recently submitted two comment letters from ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, to the U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, related to the modernization of clinical trials. The first letter provided the FDA with comments on its draft guidance, “Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.” ASCO included … (leggi tutto)