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 the final guidance, FDA is considering modifications to the Phase...
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
