WCG FDANews

FALLS CHURCH, Va. (PRWEB)
July 08, 2021

The Biden Administration’s FDA:

The First Six Months and What to Expect for the Rest of the Year

An FDAnews/CenterWatch Webinar Special Extended Edition

Thursday, July 22, 2021, 1:30 p.m.–4:30 p.m. EDT

https://wcg.swoogo.com/the-biden-administrations-fda?ref=FDAnewsEvnt

Between a new administration and lessons learned from the pandemic, all FDA-regulated companies and their advisors need to understand what’s changed at the FDA and what’s coming.

Gain insights into the Biden administration’s FDA from this special extended edition webinar. Attendees will understand the policies and programs and additional changes to come that will affect product development, approvals and enforcement.

Wayne L. Pines, president of healthcare at APCO and former associate commissioner of the FDA, will lead an expert team that will explain what the first six months of the Biden administration have brought and what to expect going forward, including the answers to:

• 
  What is likely to change at the FDA under Biden that will affect what you do every day?
• How should one plan now for upcoming changes to be ready for developments later in 2021 and in 2022 in 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 does one 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 the FDA?
• And much more!

There’s much to do to get — and stay — ahead of the FDA changes. This special extended edition webinar is how to prepare for the future.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally

to learn about our special multisite discount.

Webinar Details:

The Biden Administration’s FDA:

The First Six Months and What to Expect for the Rest of the Year

An FDAnews/CenterWatch Webinar Special Extended Edition

Thursday, July 22, 2021, 1:30 p.m.–4:30 p.m. EDT

https://wcg.swoogo.com/the-biden-administrations-fda?ref=FDAnewsEvnt

Tuition:

$297 per site

Easy Ways to Register:

Online: https://wcg.swoogo.com/the-biden-administrations-fda?ref=FDAnewsEvnt

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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