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...
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.”
High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.
Whether major drug shortages result from the COVID-19 pandemic or not, manufacturers would face greater reporting requirements, especially for APIs.