The US Food and Drug Administration (FDA) issued revised final guidance to assist sponsors, investigators, and institutional review boards conducting clinical trials during disasters and public heath emergencies (PHEs), focusing on patient safety, maintaining compliance with good clinical practice, and minimizing risk to trial integrity.
The guidance, announced in the Federal Register on 21 September 2023, has been revised to shift the focus from the COVID-19 pandemic to other public health emergencies and natural disasters. It also removes certain redundant questions and changes adverse event reporting references related to COVID-19 treatments to treating or preventing conditions related to a disaster or a PHE…
