Kyle Faget Quoted on FDA Draft Guidance for Decentralized Clinical Trials

Foley & Lardner LLP partner Kyle Faget is quoted in the Inside Health Policy article, “Telehealth, Interoperability Major Hurdles For Decentralized Clinical Trials,” commenting on the U.S. Food and Drug Administration’s (FDA) recent draft guidance on decentralized clinical trials.

As the FDA’s recent draft guidance on decentralized clinical trials requires the sponsor of the trial to indicate how telehealth will be used within the trial protocol, Faget, who is co-chair of Foley’s Health Care Practice Group, explained that the sponsor likely cannot make this decision because it is clinical in nature and should reside with the clinician interacting with the patient.

(Subscription required)