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BioBreakfast: FDA – New product approvals and studies
November 11, 2021 @ 8:30 am - 10:00 am
See event URl aboveAt the November BioBreakfast attendees will learn about new Covid-19 product approvals and soon-to-be-launched studies. Our Delaware researchers will share their recent experience successfully managing clinical trials for a new diagnostic and planning for a broad study of an important Delaware population, and we’ll be joined by a national expert on working with the FDA.
ANP Technologies CEO Ray Yin will provide an update on their newly-approved rapid antigen test for Covid-19, and Dr. Judith Ross, Director, Center for Clinical Pediatric Research (CCPR)at Nemours will share plans for an important Covid-related study. Dr. Heather Hatcher, Regulatory Scientist with the law firm Womble Bond Dickinson will provide an overview of the FDA clinical trial process and key learnings on successfully working with the agency.
Presentations will be followed by a panel discussion including Kim Englert, Quality Assurance and Clinical Research Education manager for Nemours Biomedical Research.