Meredith Manning

About Meredith Manning

For over 20 years, Meredith Manning has counseled clients on emerging legal issues of pharmaceutical regulatory law. Her goal is to help companies get drugs approved and help them succeed. Her first client was the FDA, and she now advises companies of all sizes on cutting-edge regulatory compliance issues. Clients value her “client service-oriented nature” and “the practicality of her advice.”Meredith’s focus extends from clinical trials to good manufacturing practices, drug safety, and advertising and promotion. She watches emerging issues over time, applies her insights into regulators’ thinking, and works with clients to build practical approaches to critical business processes and strategies.Meredith works on major investigations into off-label promotion, client responses to FDA warning and untitled letters, and competitor complaints. She also guides client decisions about drug advertising, drug sampling, patient support programs, and comprehensive pharmaceutical compliance programs. In this role, she has helped develop business strategies for several of the largest drug launches in recent years.She began her legal career in the Office of Chief Counsel at the FDA and moved to the DOJ as an Assistant United States Attorney for the District of Columbia. She’s been at Hogan Lovells since 2002, has served as the co-director of the firm’s Pharmaceutical Practice Group, and currently sits on the steering committee for its Life Sciences industry team.Meredith is nationally ranked in Chambers USA, Legal 500, and LMG Life Sciences. In 2012, the American Health Lawyers Associate named her a Pro Bono Champion for her work on an HIV and AIDS project in D.C. She also serves on the Board of Trustees of the Emma Willard School in Troy, New York.

Experience

1. Partner and Co-director of the Pharmaceutical and Biotechnology Practice Group

   Hogan Lovells

   Jan 2002 — Present

Education

• UCLA School of Public Health

  Master of Science (M.S.)

  1990

• Duke University

  Bachelor of Arts (B.A.), cum laude

  1984

• University of Minnesota Law School

  Doctor of Law (J.D.), Order of the Coif

  1993

Skills

• Drug Approvals
• Life Sciences
• Pharmaceutical Enforcement
• Clinical Trials
• Pharmaceutical Law
• Lifesciences
• Drug Regulation
• Prescription Drug Advertisement
• Food and Drug Regulation
• Gmp
• Strategic Planning
• Healthcare
• Pharmaceutical Regulation
• Pharmaceutical Industry
• Fda
• Consumer Protection Law