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IH08 - Turbulence Across the Atlantic: Navigating Post-Election Uncertainty at FDA (Exhibition Hall)

Wed, Mar 19, 2025 · 12:30–12:55 PM CET Innovation Hub (in Exhibition Hall), Congress Center Basel

About this session

Reversed policies and deleted guidance, startling staff reductions, cancelled meetings and events. The new administration’s executive orders and policies have sparked upheaval at the FDA with its parent agency HHS now led by a longtime vaccine skeptic and critic of the pharmaceutical industry. This session will examine the shifting regulatory landscape in the US, potential impacts on clinical programs and drug approvals, and strategies for navigating this new uncertainty. Essential for anyone with INDs or marketing applications with FDA, this discussion will provide critical insights on adapting to the evolving US regulatory landscape.

Programme:
- Setting the Scene — Helena Correia

Speakers

  • James Rawls

    Partner & Chief Regulatory Officer · Boston Biodevelopment

    Speaker

  • Helena Correia

    Founder and CEO · Boston Biodevelopment

    Speaker

  • Angela LaVonne Nelson

    Partner and Executive Vice President · Boston Biodevelopment

    Speaker