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.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
