The U.S. 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 of pushing forward modernized policies for software in/as a medical device, approving innovative new therapeutic products (53 in 2020), trying to inspect 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. In this fireside discussion, Mintz attorney Joanne Hawana and Aaron Josephson and Anthony DeMaio from ML Strategies explored 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 included:
- What more can FDA do to speed the nation’s recovery from COVID-19? How can it also ensure that medical products sold under an EUA do not negatively affect the agency’s credibility?
- Who is the likely FDA Commissioner nominee and what can we expect from him/her?
- Will FDA’s new Digital Health Center of Excellence advance digital health for drugs and devices and what are the possible impacts on regulated entities?
- Will FDA or Congress act on patient safety issues like LDT oversight, device servicing, and regenerative medicine?
- What do we expect to see out of the 2022 user fee reauthorization negotiations?