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...
In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.
A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
