The Biden Administration’s FDA

The Biden administration has brought in new policies and personnel to the entire federal health care team. The FDA remains in the news every day as it exercises its vast responsibilities. At the same time, the FDA must restore its reputation, show that it has learned from the pandemic and be prepared to effect still further changes.

All of which means you have much to do to anticipate, understand and then comply with what’s coming.

Start here, with this special extended edition webinar. Gain insights into what the Biden FDA will look like and the policies and changes it will implement to new drug and device development and approvals. How will recent and ongoing controversies affect your business?

Wayne L. Pines, president of health care at APCO Worldwide and former associate commissioner of the FDA, will lead a team that will explain what we have seen in the first six months of the Biden administration and what to expect going forward, including the answers to your burning questions.

Webinar Takeaways:

What is likely to change at the FDA under Biden that will affect what you do every day?
How should you plan now for upcoming changes to be ready for developments later in 2021 and in 2022in drug and device regulation, enforcement, drug pricing and health care innovation?
What new guidances are likely to be issued later this year?
Who are the key personnel in Biden’s FDA?
What role will HHS and the White House play under Biden? How important are politics in FDA decision-making?
What is the agenda for the new CDER director? And how have the agendas changed for the CBER and CDRH directors?
What regulatory and policy revisions initiated under the pandemic will continue as we return to normal?
What key elements from CBER’s five-year plan do you need to know about?
How will enforcement under Biden compare to that under Trump?
Will there be expedited drug and device approvals as a result of the experience with vaccine development?
What have we learned from recent drug approvals?
Will there continue to be extensive use of EUAs?
Will there be expanded opportunities in regenerative medicine?
What will happen in cannabis regulation?
What is the current status of software as medical devices?
What is the status of harmonization efforts with the EU?
What will PDUFA 2022 bring in terms of new fees but especially new authorities and new responsibilities for FDA?
And much more!

There’s much to do to get — and stay — ahead of the FDA changes. This special extended edition webinar will be invaluable in helping you think about and prepare for the future.

Wayne L. Pines
President of Healthcare
APCO Worldwide

Wayne L. Pines is a member of APCO Worldwide’s International Advisory Council and president of healthcare at APCO Worldwide. He has served as a trusted advisor to FDA leadership for several decades. He provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing challenges. He served for 10 years in senior positions at the FDA including as chief media spokesman and associate commissioner for public affairs. He has authored or edited a dozen books about the FDA and was a co-founder and long-term president of the Alliance for a Stronger FDA.

Andrea Chamblee
Senior Counsel
Wilson Sonsini Goodrich & Rosati

Andrea Chamblee is senior counsel in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati, where her practice primarily focuses on representing FDA-regulated companies, small and large alike, in efficiently navigating local and national regulatory requirements for research, clinical trials, manufacturing, commercializing, advertising, and promotion. She brings unique first-hand experience with the development and application of complex regulatory programs across regulated commodities to counsel clients at all stages of the medical product life cycle.

Kellie Combs
Partner
Ropes & Gray LLP

Kellie Combs, Partner at Ropes & Gray LLP, provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food and cosmetic manufacturers, as well as hospitals and academic institutions, on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. She is a partner in the FDA regulatory practice group and is also a co-chair of the firm’s cross-practice Digital Health Initiative. Kellie is currently advising a number of clients on issues related to the COVID-19 pandemic, including the deployment of digital health and telemedicine tools, the manufacture and distribution of personal protective equipment, and the 3D printing of medical devices and components.

Marc Scheineson
Partner
Alston & Bird

Marc Scheineson is a partner in the Alston & Bird Washington, D.C. office, where he heads Alston & Bird’s Food & Drug Law Team. He advises companies on a wide range of issues, including product approvals, marketing, clinical studies, and enforcement. Previously, he served as the associate commissioner under then-FDA Commissioner David Kessler for legislative affairs of the Food and Drug Administration. He was involved there in many agency innovations, including prescription drug user fees, debarment, medical device amendments, and nutritional labeling.

Webinar Takeaways:

Meet Your Presenters