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

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 Procter LLP, this session provides an overview of evolving FDA enforcement trends and practical insights and advice on what makes an MLR committee truly effective.

Interested in learning more about how to navigate navigate FDA's changing expectations while managing MLR risk

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Meet our Speakers

Sheryl Buchalski

Director, Promotional Review & Labeling Services
Suzan Leake

Vice President, Medical Review Services

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Elizabeth Mulkey

Partner, FDA/Life Sciences, Goodwin Procter LLP

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Sheryl Buchalski

Suzan Leake

Suzan Leake is Vice President of Medical Review Services on ProPharma's Advertising & Promotional Review team. She is a medical subject matter expert for FDA-regulated products including drugs, biologics, and medical devices.

Suzan has served as the medical representative on dozens of promotional and medical and scientific review committees, with a talent for data interpretation / application and committee leadership.

Suzan’s experience in Medical Affairs spans over 40 years and included positions in scientific leadership for multiple large, medium, and small pharmaceutical, biopharmaceutical, and device companies. She specialized in building and leading medical teams and processes to support product commercialization and has supported more than 25 commercial launches.

Suzan’s experience, education, wisdom, and wit make her unique and valuable as a consultant.

Elizabeth Mulkey

Elizabeth Mulkey is a partner in Goodwin’s Technology and Life Sciences groups and a member of the firm’s Life Sciences Regulatory & Compliance practice. She advises pharmaceutical, biologic, medical device, digital health, and consumer product companies on a broad range of FDA regulatory and compliance matters, with a particular focus on advertising and promotion issues. Elizabeth routinely supports promotional review committees, offering strategic guidance on social media content, medical affairs materials, sales training, and launch-stage commercial campaigns. She frequently works with clients to shape promotional strategies by evaluating early-stage concepts for legal risk and regularly reviews corporate communications, including press releases, investor materials, and other public-facing disclosures. In addition, Elizabeth counsels companies on product development, clinical trial compliance, interactions with FDA, and responses to enforcement actions, and she conducts internal investigations related to FDA regulatory compliance.