The US Food and Drug Administration (FDA) had an extraordinarily busy 2020, and things do not appear to be slowing down anytime soon. With its emergency use authorization (EUA) statute being tested in a pandemic for the first time, the agency has had a lot to learn while also maintaining its routine activities. Some of these activities include pushing forward modernized policies for software in or as a medical device, approving innovative new therapeutic products (53 in 2020), inspecting manufacturing facilities to ensure product quality, and grappling with thorny regulatory issues that have been building for some time, like how strictly to enforce conditions that attach to products marketed after receiving accelerated approval.
Join Mintz and ML Strategies for a fireside discussion to explore policy activities that will likely have the greatest impact on stakeholders in 2021, and how the new administration may impact the FDA in the year ahead and beyond.
Program topics will include: