2024 is an election year, which means that some of the issues that the FDA handles will be on the national debate stage. Additionally, the FDA has a new budget passed by Congress, the FDA Commissioner has identified new priorities, and the agency continues to adapt to a post-COVID environment that involves the increased use of artificial intelligence (AI), innovations in cell and gene therapies, and changes in how medical products are developed and accessed.
To help you prepare, this webinar provides expert insights and an in-depth review of potential FDA policies and programs for 2024, and what they mean for your business.
Prominent FDA-watchers and regulatory experts Wayne Pines, Cathy Burgess, Steve Grossman, Josh Oyster, and Lowell Zeta will look back at recent developments and what we can expect from the FDA in 2024 considering the regulatory and political environment. They will discuss some of the FDA’s 2024 priorities what new programs and policies will be initiated, and how companies need to plan and adjust.
- Understand the priorities, major issues, and challenges for FDA leadership in 2024.
- Learn how the FDA has changed due to Covid-19.
- Understand the role politics will play in FDA policies and decisions in the upcoming presidential election year.
- Consider how the consumer/participant voice will continue to impact FDA product decisions.
- Examine how the FDA will implement the provisions of user fee legislation.
- Assess further vaccine development.
- Analyze the monograph review process and how Rx-to-OTC switches may affect other activities.
- Discuss the Center for Biologics Evaluation and Research (CBER)’s five-year plan and its progress overseeing cell and gene therapies amid an influx of applications.
- Examine the status of AI/digital therapeutics/software regulation in the Center for Devices and Radiological Health (CDRH).
- Assess FDA decision-making around inspections, shortages, imports, supply chain issues, and promotional efforts.
- Examine the status of harmonization efforts with the EU.
Who Will Benefit:
- Biologics companies
- Cell and gene therapy companies and researchers
- Distributors and importers