The agency urges sponsors to keep patient safety “first and foremost” in determining how to continue a clinical trial during a natural disaster, public health emergency, or other crisis.
It was almost four years ago that the COVID-19 pandemic turned the world upside down, presenting a major crisis for ongoing clinical trials. The US Food and Drug Administration wants to ensure that whatever the next crisis is and whenever it arises, sponsors will never again be caught flat-footed.
That’s the core message of a new 34-page guidance document, which was issued on 21 September and co-signed by...
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
Increased support for NHS services and delivery infrastructure announced in the 11 June government spending review by chancellor of the exchequer Rachel Reeves could boost inward investment and offer new market opportunities for medtechs.
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
