Analyzing Recent Changes to FDA Approval Processes and Future Implications on Product Liability Cases

December 8, 2020 2:00pm

Sheea Sybblis
Associate General Counsel
Nestle Health Science (New York, NY)

Ashley Garry
Senior Legal Counsel
ArTara Therapeutics (Indianapolis, IN)

In connection with the Covid-19 pandemic, there have been certain changes to the processes for securing FDA approval of virus relates therapeutics, testing and preventative materials that have needed to get to market in a more expedited fashion. This panel will provide a clear understanding of:

  • The ways the government has altered FDA review and approval processes this year in order for certain products to get to market
  • The FDA’s use of “Emergency Use Authorizations” (EUAs) in connection with bringing certain products to market
    • What does the EUA process entail?
    • What findings does the FDA have to make before making such an emergency declaration
  • Understanding what you can and cannot do in terms of marketing a product governed by an EUA
    • Specific considerations and pitfalls to avoid when marketing a product that is FDA approved for one particular use and EUA approved for a new/different use
  • Assessing the different guidances issued by the FDA exercising its discretion to suspend certain enforcement actions with respect to certain product categories
  • How will the last year’s events impact the FDA in the next year and their priorities and initiatives moving forward?
  • What implications may this have on future product liability litigation?