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.
No "Phase Zero" for Biotech?
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.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
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