In this election year, FDA priorities will be discussed on the national stage. How will a new budget alter policies? And, as the agency continues to adapt to technologies such as artificial intelligence (AI), innovations in cell and gene therapies, and changes in how medical products are developed and tested, what will the future bring?

Prominent FDA-watchers and regulatory experts Wayne Pines, Jim Czaban, Betsy Foss-Campbell, Nimi Chhina and Sarah Blankstein explain it all. In a robust three-hour discussion led by Pines, they’ll look at recent developments in the drug and device environment and predict what we can expect from the FDA as we head into 2025. The outcome of the presidential election in November will impact the FDA, and companies need to plan now for all possible contingencies.

Webinar Takeaways:

  • Dig deep into current and future issues and challenges for the FDA.
  • Understand the role that this year’s election outcomes will play in FDA policies and decisions.
  • Consider how the consumer/patient voice will continue to impact FDA product decisions.
  • Examine how the FDA will use newly appropriated and user fee money for ongoing activities and new initiatives.
  • Understand CBER’s strategy and commitment to advance cell and gene therapies.
  • Discuss the status of the OTC monograph review process and how Rx-to-OTC switches will transform the marketplace.
  • Examine how AI will be used to modernize product reviews, inspections, and other FDA activities.
  • Assess current FDA policies on product shortages, imports, supply chain issues and promotional efforts.

In an ever-changing political and regulatory environment, please join us for this unfiltered examination of what the FDA is facing and what it means for your business.

Who Will Benefit:

  • Drugmakers
  • Devicemakers
  • Biologics companies
  • Cell and gene therapy companies and researchers
  • Distributors and importers