FDA’s Quality Metrics Initiative Challenged on Enforceability
This article was originally published in The Gold Sheet
Executive Summary
The pharmaceutical industry won’t let FDA force it to report quality metrics without a fight.
You may also be interested in...
US FDA Quality Metrics Initiative Continues Moving Forward … Quietly
Despite few public announcements and industry concerns, FDA's Office of Pharmaceutical Quality director says program is not dead.
Transparency Looms Large In US FDA’s Next-Pandemic Legislative Agenda
Agency’s proposals for pandemic preparedness reauthorization would build on CARES Act provisions to gain greater visibility into global pharmaceutical supply chains, while also seeking deeper understanding of manufacturing quality management activities. Also included in FY 2024 budget request: long-sought drug destruction and drug recall authorities.
US FDA ‘Brainstorms’ For Ways To Resume Pre-Pandemic Inspection Cadence
The FDA's drug inspections director discusses trends and challenges in remarks at a Georgia GMP conference, while declining to share specific ideas generated in last week’s agency brainstorming session.