US FDA Makes Case For Quality Management Maturity Ratings
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.
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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.
Sector-specific incentives may be necessary, but the FDA has not made a final decision.
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.