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.
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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.
US FDA officials tell industry that implementing a quality metrics program is an agency priority and that a rejiggered program will incorporate various elements of other quality metrics initiatives being piloted by the agency, industry and academia.