FDA’s New Commodity-Based Inspection Approach To Take Effect In May
Executive Summary
FDA’s new vertically integrated and commodity-specific approach to inspections under program alignment will finally become a reality this spring. The reorganization will retain the existing district offices, but each office will have a different focus.
You may also be interested in...
A Hiring Freeze By A Different Name: OMB Wants Agency 'Workforce Reduction' Plans
Latest Office of Management and Budget directive lifts the pause on federal hiring, but requires US FDA and others to develop long-term plans to cut staff.
Gottlieb's FDA: Specialized Groups Could Create Review Consistency, Speed
US FDA commissioner nominee might employ modular specialists to work with review divisions on issues related to gene therapies, molecularly-targeted drugs, adaptive clinical trial designs, or other complex issues.
Podcast: FDA’s Inspection ‘Program Alignment,’ New Guidance Docs Top QA/RA Hotspots In 2017
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.