FDA Think Tank: Examining the Latest FDA Initiatives Influencing the Products Liability Sphere
Co-Chair, FDA Regulatory & Compliance Practice
Morrison & Foerster LLP
Former Chief Counsel, Food and Drug Administration, 2018-2021
Rebecca K. Wood
Global Life Sciences Leadership Council
Sidley Austin LLP
Former Chief Counsel, Food and Drug Administration (FDA)
Kristin M. Kaplan
Shook Hardy & Bacon LLP (Kansas City, MO)
Morrison Foerster LLP (San Diego, CA)
- Examining FDA guidance related to controls on NDMA in Zantac and other drugs
- Exploring what future FDA approval processes and timelines will look like moving forward
- Should the industry expect to see accelerated approvals for new drugs outside of those intended to treat COVID-19? (E.g. recent accelerated approval of Alzheimer’s drug Aduhelm)
- Understanding the path forward for companies that received EUAs during the pandemic: what happens once the public health emergency is over? How will EUAs need to be converted to traditional approvals?
- How will the events of the last two years impact the FDA in the next coming year and priorities and initiatives moving forward?
- What implications may recent developments have on future product liability litigation?