Elaine Lippmann | Former FDA Official
FDA

Elaine Lippmann, Former FDA Official, FDA

Elaine Lippmann, J.D., is a Principal at Leavitt Partners based on Washington, D.C., bringing more than 15 years of leadership experience at the U.S. Food and Drug Administration (FDA) and deep expertise in pharmaceutical regulatory policy to her client work.  Elaine most recently served in a leadership role with the Office of Regulatory Policy within the Center for Drug Evaluation and Research (CDER). She advised agency senior leadership on drug policy development, implementation, and strategy and led a multidisciplinary team in advancing major regulatory and legal initiatives. She helped shape regulations, policies, and procedures on a wide range of issues central to the pharmaceutical industry, including approval pathways, competition, product quality and compliance, artificial intelligence, and advanced manufacturing.  Elaine is widely recognized as one of FDA’s foremost legal authorities on postmarketing safety, including Risk Evaluation and Mitigation Strategies (REMS), safety labeling, and postmarketing requirements. She has worked closely with industry, clinicians, and patient groups to resolve complex regulatory challenges and shape national policy. Before her federal service, Elaine practiced at a Washington, D.C. law firm, representing government and public agency clients in regulatory, transactional, and administrative litigation matters.

Appearances:



Day 1 - World Drug Safety Congress Americas 2025 @ 14:30

Presentation: Safety Label Changes

last published: 16/Oct/25 00:25 GMT

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