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# FDA Wants Quality Metrics Comments
- URL: https://www.fdaweb.com/fda-wants-quality-metrics-comments/
- Published: 2022-03-08T12:00:00.000Z
- Updated: 2026-09-14T17:35:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151314

FDA is soliciting comments on specific aspects of changes it is proposing to the drug quality metrics reporting program. The changes arise from two pilot programs with industry that were first announced in 2018, a *Federal Register* [notice](https://public-inspection.federalregister.gov/2022-04972.pdf?ref=fdaweb.com) says.

The notice says FDA believes that a change in the entities responsible for collecting and submitting quality metrics data is not needed, but it is considering changes to other aspects of the program.

Stakeholders have indicated that different industry sectors may prefer different quality metrics and so the agency would focus less on standardization of quality metrics and definitions and instead would identify practice areas that are critical to ensure sustainable product quality and availability. Manufacturers could select a metric(s) from each practice area that is meaningful and FDA would permit manufacturers to identify continual improvement opportunities. Metric definitions would not specify how they are to be calculated and reporting establishments would select the most important metric from each practice area and inform FDA how it was calculated.