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.”
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“I think one of the big issues of how the FDA regulatory framework works is that it's very rare that the FDA actually tests anything. It's all self-reported testing, by manufacturers that are also selling the product,” says Valisure CEO David Light.
Contracts in works also would help track APIs, promote gene therapy standards, improve drug compounding, help extend shelf lives for US stockpile products and improve budget execution.
Agency agrees with those who prescribe and buy drugs on need to incentivize quality. Except providers want it yesterday.