K&l Gates Health Care Triage

In this episode, Rebecca Schaefer, Michael Hinckle, and Elisabeth Lewis summarize FDA regulatory developments from 2023 and what to expect in 2024 as it relates to clinical research. They discuss the significance of the decentralized clinical trials guidance documents, highlights of the Informed Consent Guidance document, the impacts of FDA’s final rule on IRB waivers of consent, the IRB review of individual patient expanded access submissions, and the potential effects of the new proposed rule for lab developed tests.