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29
Jul

Regulatory Symposium Virtual Series

Thursday, Jul 29, 2021
9:00—10:00am

CBSA and Hogan Lovells bring you 2021’s Regulatory Symposium in four virtual sessions every Thursday from 9:00—10:00am MT starting in July.

Topics include:

  • July 15: Employment Issues and Returning to Work – Including Mandatory Vaccinations
    Speakers: Michael E. DeLarco, Office Managing Partner (New York), Hogan Lovells, and Eleanor deGolian Kasper, Associate (Colorado Springs), Hogan Lovells
  • July 22: The Future of Litigation – Prep Act, Government Authorizations, and Liability
    Speakers: Michael C. Theis, Partner (Denver), Hogan Lovells, and Emily Lyons, Senior Associate (Washington, D.C.), Hogan Lovells
  • July 29: FDA Emergency Use Authorization and the Transition Back to Normal Health Approvals – A Look at the Next 9-18 Months (End of Public Health Declaration)
    Speakers: Jodi Scott, Partner (Denver), Hogan Lovells and Wil Henderson, Senior Associate (Denver), Hogan Lovells
  • August 5: Digital Health and its Evolution Since the Beginning of COVID-19
    Speakers: Brooke Bumpers, Counsel (Washington, D.C.), Hogan Lovells and Lowell Zeta, Counsel (Washington, D.C.), Hogan Lovells and TBA

Complete Four-Session Series: Complimentary to CBSA Members/$25 Non Members
Please select all sessions you wish to attend on the registration page.

Session Details

July 29: FDA Emergency Use Authorization and the Transition Back to Normal Health Approvals – A Look at the Next 9-18 Months (End of Public Health Declaration)
Speakers: Jodi Scott, Partner (Denver), Hogan Lovells and Wil Henderson, Senior Associate (Denver), Hogan Lovells

In response to the COVID-19 pandemic the FDA has issued, and continues to issue, a large number of emergency use authorizations (EUAs) across a number of medical product categories. These authorizations are a mechanism to facilitate the availability and use of medical countermeasures (including medical devices) during public health emergencies. Under an EUA, FDA may allow the use of uncleared or unapproved medical products, or uncleared or unapproved uses of cleared or approved medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met.  But what happens when the pandemic ends? This presentation will provide an overview of how an EUA is obtained, the limitations for marketing under an EUA, and what happens to the devices that have been manufactured or placed into the market under an EUA when the public health emergency comes to an end.  This latter topic will include a review of past FDA precedent dating back to the first use of an EUA during the 2009 swine flu pandemic and an assessment of the likely FDA actions as the COVID-19 pandemic, hopefully soon, comes to an end; as well as what companies ought to be doing now to plan for the period when the pandemic comes to an end (and the EUAs are no longer in effect) to protect their ability to continue to market their products.

Review in-depth descriptions of each session.

Thank you to our event sponsor:
Thank you to our sustaining sponsor: