Podcast: FDA’s Inspection ‘Program Alignment,’ New Guidance Docs Top QA/RA Hotspots In 2017
Executive Summary
US FDA has reportedly selected three cities that will be home to new agency divisions dedicated to coordinating inspections of device manufacturers under its “program alignment” inspection initiative. This development is just one of many that will touch quality and regulatory professionals this year, longtime industry insider Steve Niedelman says in this Medtech Insight podcast. Other topics to watch: FDA’s recent string of new guidances; the 21st Century Cures Act.