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# 2 New Quality Metrics Feedback Programs
- URL: https://www.fdaweb.com/2-new-quality-metrics-feedback-programs/
- Published: 2018-06-28T12:00:00.000Z
- Updated: 2026-09-15T00:16:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141790

FDA says it has started two new programs to gather feedback on using quality metrics to modernize pharmaceutical quality systems and advance innovation. An agency *Small Business Buzz* online [post](http://s2027422842.t.en25.com/e/es?s=2027422842&e=104817&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=a4e41efcbadf4ddc967f5d0b54dac63d&elqaid=4082&elqat=1&ref=fdaweb.com) says the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program build on stakeholder comments requesting continued dialog on quality metrics, and provide ways for industry to engage the agency and inform its use of quality metrics.

Under the Quality Metrics Feedback Program, FDA is encouraging NDA holders to request Type C formal meetings and encouraging ANDA holders to submit pre-ANDA meeting requests to open discussions on quality metrics for specific products. The agency is also starting a pilot study to gain feedback from other types of establishments, including active pharmaceutical ingredient establishments, contract manufacturing organizations, over-the-counter monograph products establishments, or marketed unapproved falsified drug products establishments.

The voluntary Quality Metrics Site Visit Program offers experiential and firsthand learning opportunities to FDA staff involved in developing the agency’s quality metrics program. The post says that agency staff will gain exposure to robust quality metrics programs through on-site visits, tours of operations, and discussions with establishments to assist staff in further developing the quality metrics program.