Regulatory Education For Industry Redi Annual Conference 2023 %e2%80%93 Day 2 %e2%80%93 Session 1

Summary

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