In-Use Microbial Stability
The purpose of the working group is to share industry experience, to define and implement strategies to clarify FDA expectations, and to collectively collaborate with FDA on this topic. This will allow sponsors to apply risk-based approach to appropriately justify the in-use hold times and provide more flexibility to the hospitals. This can be achieved through the following objectives.
- Gather cross-industry experience on current microbial testing practices and challenges, microbial growth data interpretation and assignment of hold times
- Share industry experience with feedback received from FDA and ROW HA
- Define and implement strategy for understanding FDA expectations on study design, data interpretation, hold time assignment, and applicability to early phase programs
- Define and implement strategy to collaborate with FDA (potential topics include improvements to microbial challenge study design and guidelines for microbial growth interpretation/hold time assignment)
- Develop a position paper based on collective feedback and regulatory discussions/engagement.