Evolving FDA Expectations: How High-Functioning MLR Teams Manage Risk in 2026

About the Webinar

As FDA promotional enforcement activity continues to evolve, Medical, Legal, and Regulatory (MLR) teams are facing increased pressure to move quickly while managing compliance risk with greater precision. With renewed scrutiny around social media, influencer engagement, Direct-to-Consumer (DTC) messaging and data-driven claims, as well as the potential for additional enforcement actions ahead, organizations must ensure their MLR committees are structured to function effectively, collaboratively, and strategically.

In partnership with Goodwin, this webinar will take attendees inside a hypothetical high-performing MLR committee to examine what truly makes these cross-functional teams work. Drawing on recent FDA enforcement letters and emerging promotional trends, our panel of experienced reviewers will explore how medical, legal, and regulatory perspectives intersect when evaluating risk, interpreting data, and supporting business objectives.

Our discussion will highlight how FDA expectations around evidence, safety, and claim substantiation are being reinforced through enforcement, including common themes seen in the recent FDA letters focused on DTC advertising. Panelists will also address how companies are approaching newer promotional strategies, such as influencer partnerships, peer-to-peer engagement, and patient education initiatives, and the distinct considerations each MLR function brings to these discussions.

What You’ll Learn

During this session, our panel will discuss:

• How to build an effective MLR partnership and clearly define the role of each function
• What recent FDA enforcement activity reveals about evolving promotional expectations
• Best practices for interpreting and presenting clinical data accurately and compliantly
• Managing risk in emerging promotional channels, including evolving social media and influencer strategies
• Real-world examples of how medical, legal, and regulatory perspectives align and differ within the MLR process
• How to pave a clear path forward for promotional review in an uncertain regulatory environment

Key Takeaways

By attending this webinar, you will walk away with: 

• A clearer understanding of how risk assessment is shared across medical, legal, and regulatory teams
• Insight into why strong legal counsel remains critical as promotional strategies evolve
• Practical guidance on how to "set the stage" for an MLR committee that can adapt to changing FDA enforcement priorities while enabling compliance innovation

Stay ahead of evolving FDA enforcement trends and gain practical insight on what makes an MLR committee truly effective.

Unable to join? Register and you will receive the recording after the live session.