A new administration in Washington has brought with it sweeping change across key health regulatory agencies—and life sciences companies are feeling the impact. From FDA resource shifts to emerging trade tensions and Congress-led policy proposals, the current landscape poses real and immediate risks to drug and device development, supply chain stability, and regulatory timelines.
In this edition of Stirred & Shaken, join regulatory and medtech experts for a 60-minute discussion exploring how organizations can anticipate and de-risk these changes—and where they may find opportunity amid uncertainty.
Key questions for discussion:
Approvals: How can companies future-proof submissions to an FDA facing personnel and budget challenges? What shifts in priorities should be expected from FDA and HHS?
AI in Medicine: What do changing attitudes in Washington mean for regulation of AI/ML in medtech and digital health?
Global Collaboration: How could a more isolationist U.S. stance impact regulatory harmonization and cross-border R&D?
Controversial Categories: How will increased political scrutiny of areas like oncology, rare disease, vaccines, and reproductive medicine affect approval pathways?
Supply Chain & Tariffs: What steps can companies take to protect supply chains amid policy uncertainty and reshoring pressure?
Emerging Tech: How should innovators in fields like gene therapy or personalized medicine navigate regulatory ambiguity?