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Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or...
Draft Guidance provides recommendations such as design considerations, conduct of remote clinical trial activities, use of digital health technologies to remotely acquire data, roles of the sponsor and investigators, informed consent and institutional review board oversight
The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics,...
This is Part 1 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its commitments set forth under the Prescription Drug Under Fee Act...
On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic…