Small US biotechs cite FDA barriers to first-in-human trials: survey

A survey of 37 US small biotech executives reveals that FDA regulatory hurdles, particularly delays and costly clinical holds, are driving early-stage developers to conduct first-in-human trials offshore despite a preference to run them in the US. The survey highlights specific regulatory concerns, including the application of the FDA's 1/10 rule and unpredictability in review processes, which threaten the US clinical trial ecosystem for rare and serious diseases.

This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it.