“In January 2021, President-elect Biden will assume office and begin the transition to new leadership in the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). Without question, a focus on Coronavirus Disease 2019 (COVID-19) vaccines, treatments, and new technologies to identify, cure, and reduce the transmission of the virus will continue to be of paramount importance to President-elect Biden, as these matters were the centerpiece of his campaign. This GT Alert will also address additional changes in the broad areas of drugs, medical devices, biologics and foods, with a special emphasis on emerging technologies (especially through the Emergency Use Authorization (EUA) process), dietary supplements, remote patient monitoring/telehealth, and vaccines.”
COVID-19 FDA Efforts (Vaccines)
“President-elect Biden has taken action to confront the COVID-19 pandemic. He announced a COVID-19 task force made up of physicians and health experts. The three co-chairs include: Dr. Vivek Murthy, surgeon general during the Obama administration; Dr. David Kessler, FDA commissioner under Presidents Bush and Clinton; and Dr. Marcella Nunez-Smith, associate dean for health equity research at Yale University. The early goals of the task force are to work with state and local health officials on a plan to address the virus and its racial disparities and to develop a plan for reopening schools and businesses…”
Digital Health
“Over the last few years, FDA has spent significant time on the policy agenda promoting digital health. This helped to advance digital health technologies and artificial intelligence/machine learning at an unparalleled pace. FDA has put forth a series of regulatory initiatives and creative approaches in reforming the agency’s review of the utilization of real-world data in regulatory review process, introduction of an initial framework for artificial intelligence/machine learning products, as well as prescription drug-use-related software, a pre-certification program pilot to facilitate the development of software as a medical device, and the establishment of a Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH)…” Read the full article here.
Source: The FDA Under a Biden Administration – By Nancy E. Taylor, Justin J. Prochnow, Chia-Feng Lu, Michael R. Goodman, and Samantha R. Beck, November 12, 2020. Greenberg Traurig.
