US FDA Makes Case For Quality Management Maturity Ratings
Executive Summary
High ratings could strengthen company financial performance, agency suggests. But stakeholders would need to understand the difference between site QMM and product quality for the incentives to work properly. More details to follow in upcoming workshop.
You may also be interested in...
Brookings’ Drug Shortages Remedies Target Both Hospitals And Manufacturers
Incentives would give hospitals reason to pay for quality and reliability, while loans would help generics manufacturers upgrade sterile injectables facilities and feds would buffer supply chains with additional inventories, the policy think tank says. All it would take is an act of Congress.
What Carrots Will US FDA Offer For Quality Management Maturity Participation?
Sector-specific incentives may be necessary, but the FDA has not made a final decision.
The Quality Lowdown: ICH Q9, FDA QMM, THC Impurities And Recertified MAPPs
Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.