Drug Shortage Plan Would Grade Firms To Encourage High-Quality Production
US FDA task force recommends a rating system that purchasers could rely on to reward manufacturers with robust management systems.
You may also be interested in...
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.
US FDA Launches Quality Maturity Pilots That Reward High-Performing OTC, Rx Manufacturers
One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”
US FDA Launches Quality Maturity Pilot Program That Rewards High-Performing Manufacturers
High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.