FDA Quality Metrics Proposal Sparks Objections, Disarray
This article was originally published in The Gold Sheet
Executive Summary
Pharmaceutical manufacturers argued FDA can’t make them report quality metrics data, but there was little else they could agree on in their initial reaction to the complex, enforceable reporting scheme FDA has proposed in its draft quality metrics guidance.
You may also be interested in...
Public-Private Consortium To Strengthen Essential Medicines Supply Under White House Initiative
President Biden’s 100-day plan relies on Defense Production Act authorities to increase resilience of critical domestic pharmaceutical supplies.
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.
FDA Urges Full Participation In Quality Metrics Program
Despite the voluntary nature of US FDA’s program, an agency official urges full participation. Without data from such participation, FDA will not be able to predict drug shortages and industry will not see the benefits of reduced inspections and streamlined change control.