Providers Support FDA Quest For Public Drug Manufacturing Quality Ratings
Agency agrees with those who prescribe and buy drugs on need to incentivize quality. Except providers want it yesterday.
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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.
Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.