FDA+ roundup: Lessons learned from two quality ratings pilots; Expanded FDA collab with organ-on-a-chip company
The FDA since at least 2019 has been fiddling with the idea of adding drug/active pharmaceutical ingredient (API) manufacturing quality ratings or scores as part of an attempt to promote better manufacturing practices industrywide.
The initial idea led to two pilot programs — one with seven domestic sites making finished products and the other looking into eight foreign sites making APIs marketed in the US — and Jennifer Maguire, the FDA’s director of the Office of Quality Surveillance, and CDER colleagues are now explaining the results in a recent publication in the AAPS Journal, concluding that expanding such a quality program will be beneficial for multiple stakeholders:
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