Note: This is Part 2 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 Reauthorization Performance Goals and Clinical Trial Diversity and Modernization mandates established by Congress under the Food and Drug Omnibus Reform Act of 2022 (FDORA), including developments on the intersection and use of digital health technology in clinical trials and clinical trial diversity. Part 1, covering the Digital Health Technologies framework is available here.
The Food and Drug Administration (FDA) has released draft guidance intended to help modernize the design and conduct of clinical trials by making them more efficient and enabling them to incorporate the newest technological and methodological advancements into their design.
FDA continues to issue guidance in the wake of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which in part requires FDA to provide further oversight and guidance on “Clinical Trial Diversity and Modernization.” Under Section 3607(c) of FDORA, consistent with its obligations modernize clinical trials, FDA is specifically required to “work with foreign regulators pursuant to memoranda of understanding or other arrangements governing the exchange of information to facilitate international harmonization of the regulation” as it pertains to innovative approaches to clinical trial design and implementation.
Continue Reading FDA Issues Draft Guidance on Good Clinical Practice in Ongoing Clinical Trial Modernization Efforts