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Webinar Recording: FDA in 2021: A Look Ahead

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?

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Authors

Joanne S. Hawana counsels global Mintz clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, electronic nicotine systems, and medical devices.

Aaron L. Josephson

Senior Director

Aaron L. Josephson is a Senior Director of ML Strategies who advises clients on health care policy issues related to medical devices and pharmaceuticals. Earlier, he was with the US Food and Drug Administration, including as a senior policy advisor in the Center for Devices and Radiological Health.

Anthony M. DeMaio

Director of Government Relations

Anthony M. DeMaio, Director of Government Relations of ML Strategies, draws on over a decade of experience in government affairs and communications - working with members of the Massachusetts congressional delegation - to lobby on behalf of a variety of clients and assist them with congressional investigations and media messaging.