Regulatory Education For Industry Redi Annual Conference 2022 Day 1 Part 1

Summary

Robert M. Califf, MD, Commissioner of Food and Drugs at FDA, delivers the keynote address to the Kevin Bugin, Deputy Director for Operations for the Office of New Drugs (OND) provides a background and overview of the ... The devices track will provide an overview and highlights of how to get a new medical device to market. It will also discuss some ... The plenary will take a closer look at the impact of user fee legislation, how the FDA advances programs through user fees ... CAPT Connie Jung, Senior Advisor for Policy in the Office of Drug Security, Integrity, and Response (ODSIR), reviews advances in ... FDA experts: *Review the new BsUFA III commitments, focusing on supplement categories and associated timelines, guidance ... Content in this video provided updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and ... Seyoum Senay, Supervisory Operations Research Division of Data Management Services and Solutions (DDMSS) from the Office ... FDA speakers outline the evolution and modernization of Electronic Submissions Gateway (ESG) along with plans for the next ... Kerry Jo Lee, MD, Associate Director for Rare Diseases in the Office of Rare Diseases, Pediatrics, Urologic and Reproductive ... Presenters in the devices track discuss the following topics: Demystifying Medical Device