The Food & Drug Administration's recent guidance on "Phase Zero" trials has been embraced as a way to help speed up the development process. But for biotech firms, the window of opportunity may be already closed: less than six months after issuing the final guidance, FDA is considering modifications to the Phase Zero policy due to safety concerns.
The Food & Drug Administration’s recent guidance on
"Phase Zero" trials—early clinical testing of minute doses of
drugs and biologics—has been embraced by some companies as a
way to help speed up the development process.
But for biotech firms, at least, the window of opportunity may be already closed: less than six months after issuing...