Lynn Mehler

Lynn Mehler is chair of the Life Sciences Regulatory practice at Paul Hastings and is based in the firm’s Washington, D.C. office. She counsels pharmaceutical, biotechnology and other life sciences clients on FDA and DEA regulatory challenges across the product life cycle. Having spent more than 12 years in the FDA’s Office of Chief Counsel, Lynn’s frontline experience and understanding of the nuances of regulatory obligations and processes enable her to advise clients of all sizes — from precommercial companies to global pharmaceutical powerhouses — on their most business-critical regulatory matters.

Lynn brings particular depth of experience in providing strategic guidance on FDA engagement and advocacy in the approval processes for new drugs and biologics. She also has extensive experience helping clients navigate drug safety issues, including risk evaluation and mitigation strategies (REMS), post-market studies and pharmacovigilance.

Lynn is a leading regulatory authority on the development and marketing of controlled substances. While at the FDA, she served as the primary attorney on all issues related to controlled substances, liaising with DEA and gaining in-depth understanding of both FDA and DEA regulatory processes. Lynn uses this unique insight to develop effective strategies to support clients’ research and development, clinical trials, regulatory approval, product marketing and compliance for controlled substances.

William & Mary Law School, J.D., Order of the Coif

The College of Wooster, B.A., Phi Beta Kappa