Meredith Manning

"Meredith Manning focuses her energies on both routine and on extraordinary client needs for drug companies. This dual approach serves her clients well, as it prevents emergent issues from growing. On-going service to her clients includes counseling on day-to-day compliance problems such as clinical trials, [and] advertising and promotion..."

LMG Life Sciences

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.

Awards and recognitions

2010-2017

Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia)
Chambers USA

2007, 2013 - 2018

Food and Drugs
Washington, D.C. Super Lawyers

2004, 2009, 2011, 2014

Washington's Top Lawyers: Food and Drug
Washingtonian

2007, 2013-2018

Administrative Law
Washington, D.C. Super Lawyers

2014

Healthcare: Life Sciences
Legal 500

2012

Pro Bono Champion
American Health Lawyers Association

2011-2012

Regulatory
PLC Life Sciences Cross-border Handbook

2010-2012

Healthcare/Pharma
Ethisphere, Attorneys Who Matter

2007-2009

USA - Life Sciences: Regulatory, Highly Recommended
PLC Which Lawyer?

2007

Food and Drug Administration
Washington, D.C. Super Lawyers

Education and admissions

Education

J.D., Order of the Coif, University of Minnesota Law School, 1993

M.S., University of California, Los Angeles, School of Public Health, 1990

B.A., cum laude, Duke University, 1984

Memberships

American Health Lawyers Association

Member, Food, Drug, and Law Institute

Bar admissions and qualifications

Colorado

District of Columbia

Court admissions

U.S. Court of Appeals, District of Columbia Circuit

U.S. District Court, District of Columbia

Representative experience

Lead regulatory counsel in a major federal misbranding investigation.

Lead a team advising on patient support programs designed to support launch of a major oncology drug.

Handled an OIG advisory opinion request regarding a free drug program.

Routinely review proposed promotional materials and programs for major drug products sold in the U.S.

Craft responses to FDA enforcement letters on GMP and drug advertising.

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