Pink Sheet has an update this week on the FDA’s Quality Metrics initiative – US FDA Quality Metrics Initiative Continues Moving Forward … Quietly.
This is behind a firewall so may not be viewable by all.
The major takeaways were:
- The initiative is still happening
- the FDA wants to remind companies why they are doing this in the first place
- They are starting a pilot real “soon” now
These metrics have been a hard sell within Pharma. I’ll be curious what steps the FDA will be taking to rebrand the effort.