Regulatory Education For Industry Redi Annual Conference 2022 Day 2 Part 3

Summary

Suranjan De, Deputy Director of FDA discusses: * The new PMR commitments under PDUFA VII; * How CDER is working to advance rare disease cures with the ... Kevin Bugin, Deputy Director for Operations for the Office of New Drugs (OND) provides a background and overview of the ... Kerry Jo Lee, MD, Associate Director for Rare Diseases in the Office of Rare Diseases, Pediatrics, Urologic and Reproductive ... The drugs track will continue its focus on PDUFA VII commitments. Subject matter experts will provide cutting edge insights and ... CAPT Connie Jung, Senior Advisor for Policy in the Office of Drug Security, Integrity, and Response (ODSIR), reviews advances in ... FDA discusses considerations and best practices throughout a human drug recall life cycle including when to conduct a recall, ... The FDA discusses *How clinical trials are advancing through the use of DHTs, DCTs and point of care trials along with providing ... The biologics track will focus on the developmental and FDA experts: *Review the new BsUFA III commitments, focusing on supplement categories and associated timelines, guidance ... The FDA will present: *How to leverage SBIA's Resources; *An overview of the CDER STAR Pilot Program and discuss ...