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Session 1: FDA News Feed: 2017
Session Chair(s)
Rachel Turow, JD, MPH
Managing Counsel, FDA Regulatory
Walmart, Inc., United States
FDA regulation of combination products has seen huge advances in recent years. Both PDUFA VI and 21st Century Cures have included programmatic changes for combination products, and FDA has been busy issuing guidance and regulations as well as implementing organizational changes to aid in the review of combination products. The Office of Combination Products will give an update on all of these aspects and forecast some future issues we might see addressed under the new FDA Commissioner.
Learning Objective :
Speaker(s)
FDA News Feed: 2017
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC