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:
- What more can FDA do to speed the nation's recovery from the COVID-19 pandemic? 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 or 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?
When
Thursday, February 18, 2021
12:00 - 1:00 pm ET // 9:00 - 10:00 am PT
This is an online event.
Moderator
- Anthony M. DeMaio
Director of Government Relations, ML Strategies
Speakers
- Joanne S. Hawana
Member, Health Law Practice, Mintz - Aaron Josephson
Senior Director, ML Strategies