1:30 PM - 1:40 PM

Welcome & Introduction

  • Are there noticeable differences between the Trump FDA and the Biden FDA?
  • What the key areas where we can expect change?

1:40 PM - 2:10 PM

Biden Administration HHS/FDA Team: New Personnel, New Policies

  • What have been the key personnel changes in Biden’s first six months?
  • How will these personnel changes play out in the long run, and who exactly is calling the shots?
  • What is the relationship between the White House, HHS, FDA & Congress?     

2:10 PM - 3:00 PM

Drug and Device Development and Approval

  • Will the relationship between CDER, CBER, CDRH and the Office of Regulatory Affairs change?
  • What changes have we seen and will we see in the future in these centers/offices?
  • What are the most important recent policy developments in the pharmaceutical and medical device development, approval, and regulatory space?
  • What is the impact of COVID-19 on drug and device approval?
  • What is the impact of EUAs, and what does a transition plan look like?
  • Will we see a shift in CDRH policy regarding diagnostics/LDTs?
  • Will there be a new normal for remote/virtual FDA interactions?
  • What’s the impact of COVID-19 policies on clinical trials, including use of RWE, and adaptive/decentralized trials? 
  • What about new Centers of Excellence?

3:00 PM - 3:10 PM                            


3:10 PM - 4:30 PM

Challenges Facing a New Commissioner

  • What can we expect with PDUFA 22?
  • How will FDA continue to address the opioid crisis?
  • What steps may FDA take to increase access to generic drugs and biosimilars?
  • How will FDA support innovation in gene therapies and products to treat rare diseases?
  • What developments are on the horizon for regulation of digital health technology?
  • How will FDA manage inspections and clear the backlog post-pandemic?
  • Can we expect to see changes in FDA’s approach to oversight and enforcement related to advertising and promotion?