Regulatory Education For Industry Redi Annual Conference 2022 Day 2 Part 1

Summary

Kevin Bugin, Deputy Director for Operations for the Office of New Drugs (OND) provides a background and overview of the ... The FDA will present: *How to leverage SBIA's Resources; *An overview of the CDER STAR Pilot Program and discuss ... Kerry Jo Lee, MD, Associate Director for Rare Diseases in the Office of Rare Diseases, Pediatrics, Urologic and Reproductive ... Suranjan De, Deputy Director of Content in this video provided updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and ... The drugs track will continue its focus on PDUFA VII commitments. Subject matter experts will provide cutting edge insights and ... The devices track will provide an overview and highlights of how to get a new medical device to market. It will also discuss some ... FDA experts: *Review the new BsUFA III commitments, focusing on supplement categories and associated timelines, guidance ... Robert M. Califf, MD, Commissioner of Food and Drugs at FDA, delivers the keynote address to the The FDA discusses *How clinical trials are advancing through the use of DHTs, DCTs and point of care trials along with providing ... FDA discusses considerations and best practices throughout a human drug recall life cycle including when to conduct a recall, ... The biologics track will focus on the developmental and CAPT Connie Jung, Senior Advisor for Policy in the Office of Drug Security, Integrity, and Response (ODSIR), reviews advances in ...