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