Lexology January 12, 2026
Sidley Austin LLP

By: Becky Wood, Raj Pai, Torrey Cope, Emily Marden, Diane McEnroe, and Deeona Gaskin

As 2026 begins, there is much to look forward to as companies and investors in the life sciences and medtech industries navigate a profoundly changing regulatory environment at FDA. With 2025 witnessing generational changes at FDA, we’re keeping an eye on opportunities and challenges for the year to come. Here are key areas we’re watching.

  1. Rapid Leadership and Policy Changes at FDA Raise Questions and Bring Opportunity.

With fast-moving leadership and policy changes, as well as reductions in force, FDA continues to witness profound changes with the loss of institutional memory and long-time career leadership. Many have questioned the impact of these rapid changes...

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