Celesq® Attorneys Ed Center

FDA in the Year of COVID – How FDA Tackled the Pandemic and What to Expect from FDA in 2021

Program Number: 3144

Program Date: 02/11/2021

Description

Over the past year, industries all over the world have experienced disruptions and have been forced to adapt to the COVID-19 pandemic. Notably, the Food and Drug Administration (“FDA”) has been thrust to the forefront of the battle against COVID-19, and emergency use authorizations (“EUAs”) and Operation Warp Speed are now hot topics. EUAs have allowed FDA to pivot and make speedy decisions that help save lives, but EUAs aren’t without their pitfalls. Additionally, Operation Warp Speed has been an impressive scientific endeavor, helping to bring vaccines to market in record time. As FDA has adapted quickly to the most up to date knowledge about this novel virus and changing scientific data, including real world evidence, what is in store for 2021? A new administration begins on January 20, 2020, and this new administration will bring different goals and plans for fighting COVID-19. Looking to 2021, we will see whether FDA’s operations go back to their pre-pandemic normal and how FDA might continue to use real world evidence to support important regulatory decisions.

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Available in states

California, Colorado Eligible, Florida, Georgia, New Jersey Eligible, New York, Texas Self Study

Credit Information

50 minute credit hour - 1.00 General CLE credit
60 minute credit hour - 1.00 General CLE credit

State Program Numbers

Presenters


Alexander Alfano, Esq.

Axinn, Veltrop & Harkrider LLP

Alex Alfano is an attorney in Axinn, Veltrop & Harkrider LLP’s Intellectual Property and Food and Drug Administration practice groups. His patent litigation practice focuses on biotechnology, pharmaceuticals, medical devices, diagnostics, and the life sciences. His experience includes pre-litigation client counseling, inter partes proceedings, cases brought under the Hatch-Waxman Act, and counseling relating to FDA matters.

 

Michelle Divelbiss, Esq.

Axinn, Veltrop & Harkrider LLP

Michelle Divelbiss is an attorney in Axinn, Veltrop & Harkrider LLP’s Intellectual Property and Food and Drug Administration practice groups. Her practice involves patent litigation, particularly cases brought under the Hatch-Waxman Act, and counseling relating to FDA matters.

 

Chad Landmon, Esq.

Axinn, Veltrop & Harkrider LLP

Chad Landmon chairs Axinn, Veltrop & Harkrider LLP’s Intellectual Property and Food and Drug Administration Practice Groups and focuses his practice on patent litigation and counseling and food and drug law, with an emphasis on pharmaceuticals, biologics, medical devices, and human tissue products. He maintains a particular focus on patent trial work and FDA litigation, having served as a first chair trial lawyer on multiple cases and having litigated over 50 cases during the past 10 years alone, many of which have included products with billions of dollars in annual sales.

 

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