US FDA Contracting Update: From Rating Site Quality Maturity To Blocking COVID-19 Scams
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.
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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.
By focusing on short-term stability, US FDA paves way for quicker emergency use authorization without compromising on quality.