F2I Partners LLC

In biopharma, few things cause more collective eye-rolls than a new FDA guidance that feels. Open to interpretation or that seems to repeat the same “old” news in slightly new packaging. It’s easy to think, “Haven’t we heard this before?” But maybe that repetition isn’t redundancy. Maybe it’s reinforcement. Because every time the agency revisits familiar ground  risk-based thinking, data integrity, process understanding it’s reminding us that these aren’t trends. They’re foun