FDA Think Tank: Examining the Latest FDA Initiatives Influencing the Products Liability Sphere

December 7, 2021 11:00am

Stacy Cline Amin

Stacy Amin
Partner
Co-Chair, FDA Regulatory & Compliance Practice

Morrison & Foerster LLP
Former Chief Counsel, Food and Drug Administration, 2018-2021
(Washington, DC)

Rebecca K. Wood
Partner
Global Life Sciences Leadership Council

Sidley Austin LLP
Former Chief Counsel, Food and Drug Administration (FDA)
(Washington, DC)

Kristin M. Kaplan
Of Counsel
Shook Hardy & Bacon LLP (Kansas City, MO)

Moderator:

Julie Park
Partner
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?