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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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.
FDA Expedites ANDA Postapproval Manufacturing Changes
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.