FDA, Defense to share patient data in bid to improve safety in the US
This article was originally published in Clinica
The US Food and Drug Administration and the Department of Defense (DoD) have agreed to share patient information in an effort to improve their mutual understanding of the safety of medical devices, drugs and biologics and how patients use them, writes April Fulton.
You may also be interested in...
The biopharma industry has struggled to recruit patients into clinical trials that adequately reflect the diverse patient populations they hope to reach with new products. Failure to improve minority subgroup participation now will cost trial sponsors later.
A flurry of US biosimilar launches over the past few months has opened several molecules to true, multi-source competition, with a range of pricing strategies seen from competitors. However, some brands that already face biosimilar competition elsewhere in the world are still poised to enjoy a significant period of exclusivity in the US, such as AbbVie’s Humira.
It is the question that continues to exercise the minds of management boards in the medtech industry even as digital health care tools become increasingly ingrained in commercial R&D and operations – and in patient treatment pathways.