Foley Hoag Co-Chair of the Healthcare Department and Chair of the FDA Practice, Bryant Godfrey, will speak at NEHEN’s “Navigating the Shifting U.S. and Global Healthcare Regulatory Landscape” panel on September 29th. This timely networking event will cover healthcare’s most critical topics: the evolving regulatory landscape that’s transforming how products are developed, reviewed, and brought to market in the U.S. and around the world.
Panel discussion topics include:
- Impact of FDA staff reductions on reviews, engagement, and promotional enforcement
- Restructuring within the Office of Prescription Drug Promotion and its effect on product launches
- Regulatory implications of AI and the FDA’s use of tools like Elsa in product review
- FDA’s draft guidance for AI-enabled medical devices and how it compares to EU oversight
- Pre-market cybersecurity requirements and software bill of materials (SBOMs)
- Data governance and GDPR compliance in an interconnected ecosystem
- Global regulatory strategies and the challenge of multi-market alignment for startups
- Best practices for agile regulatory planning and cross-functional alignment
Following the panel, attendees will join a lively, moderated Q&A session, where questions and insights will enrich the conversation.
