Quality Metrics Program Update: We Asked and FDA Answered
By: Sandra K. Rodriguez, Market Analyst
The Quality Metrics program is a key step in the Agency’s objective to encourage industry to implement state-of-the-art, innovative quality management systems that drive industry to focus on improving product quality, rather than simply ensuring compliance to regulatory requirements.
FDA recently published two announcements on the Quality Metrics program in the Federal Register:
- CDER intends to further develop a Quality Metrics Program through formal meeting requests and a pilot study to gain feedback from those establishments for which meeting requests do not apply
- CDER and CBER are initiating a 2018 Quality Metrics Site Visit Program to assist the Agency in understanding existing programsii
These announcements prompted a number of industry executive to reach out to Axendia to understand FDA’s current thinking on Quality Metrics.
For a first-hand account, we reached out to FDA with a few questions – we asked and they answered. 
AXENDIA: What drove the delays in the program?
FDA: There were many comments submitted to the docket after the revised draft 2016 guidance was published. The comments generally indicated that additional feedback and a pilot would be useful. Further, we took time to listen to additional comments and feedback from industry and industry trade organizations provided at conferences and presentations. We determined that our next steps should be a Feedback Program and Site Visit Program which would allow individual companies an opportunity to discuss their approaches from different sub-sectors of the industry. Continue reading