US biotechs prefer doing FIH trials in USA but regulatory hurdles sending them abroad
A new survey reveals that US biotechnology companies focused on developing treatments for rare and serious diseases overwhelmingly prefer to conduct first-in-human (FIH) clinical trials in the USA.
However, historical obstacles posed by the US Food and Drug Administration (FDA) are prompting them to seek development overseas – in Australia, Europe, and China. The survey of 37 US biotechnology executives was conducted by the Biotech Consortium to Accelerate Innovation (BCAI) in partnership with MassBio.
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