Meredith Manning
Partner
Washington, D.C.

Biography
For over 20 years, Meredith Manning has counseledclients on emerging legal issues of pharmaceuticalregulatory 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. Clientsvalue her "client service-oriented nature" and "thepracticality of her advice."

Phone

Meredith's focus extends from clinical trials to good
manufacturing practices, drug safety, and advertisingand promotion. She watches emerging issues overtime, applies her insights into regulators' thinking, andworks with clients to build practical approaches tocritical business processes and strategies.

Practices

Meredith works on major investigations into off-label
promotion, client responses to FDA warning anduntitled letters, and competitor complaints. She also
guides client decisions about drug advertising, drug
sampling, patient support programs, andcomprehensive 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 ChiefCounsel at the FDA and moved to the DOJ as anAssistant United States Attorney for the District ofColumbia. She's been at Hogan Lovells since 2002, hasserved as the co-director of the firm's Pharmaceutical
Practice Group, and currently sits on the steeringcommittee for its Life Sciences industry team.

+1 202 637 6585

Fax
+1 202 637 5910

Emailmeredith.manning@hoganlovells.com

Investigations, White Collar, andFraud
Marketing and Advertising
Pharmaceuticals and Biotechnology
RegulatoryIndustries
Life Sciences and Health Care

Areas of focus
False Claims Act and Qui Tam
Product Development and Approval
Clinical Trials
Pharmaceuticals and Biotechnology
Cell, Tissue, and Gene Therapies

Meredith is nationally ranked in Chambers USA, Legal
500, and LMG Life Sciences. In 2012, the American
Health Lawyers Associate named her a Pro BonoChampion for her work on an HIV and AIDS project inD.C. She also serves on the Board of Trustees of theEmma Willard School in Troy, New York.

Representative experience
Lead regulatory counsel in a major federal misbranding
investigation.
Lead a team advising on patient support programsdesigned to support launch of a major oncology drug.

Education and admissions
EducationJ.D., University of Minnesota Law
School, Order of the CoifM.S., University of California, Los
Angeles, Fielding School of Public
HealthB.A., Duke University, cum laude

Handled an OIG advisory opinion request regarding afree drug program.

Bar admissions andqualifications

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

Colorado
District of Columbia

Craft responses to FDA enforcement letters on GMPand drug advertising.

Court admissions
Awards and rankings
Healthcare: Pharmaceutical/Medical Products
Regulatory (District of Columbia), Rank 3, Chambers
USA, 2010-2018
Food and Drugs, Washington, D.C. Super Lawyers,
2007, 2013 - 2018
Washington's Top Lawyers: Food and Drug,
Washingtonian, 2004, 2009, 2011, 2014
Administrative Law, Washington, D.C. Super Lawyers,
2007, 2013-2018
Healthcare: Life Sciences, Legal 500, 2014
Pro Bono Champion, American Health Lawyers
Association, 2012
Regulatory, PLC Life Sciences Cross-border
Handbook, 2011-2012
Healthcare/Pharma, Ethisphere, Attorneys WhoMatter, 2010-2012
USA - Life Sciences: Regulatory, Highly
Recommended, PLC Which Lawyer?, 2007-2009

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

Accolades"[C]lient service-oriented nature."

Chambers USA"Meredith Manning focuses herenergies 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. Ongoing service to her clients includes
counseling on day-to-dayFood and Drug Administration, Washington, D.C.
Super Lawyers, 2007

Latest thinking and events
NewsNinth Circuit strengthens FDA authority to enforce
drug regs against certain stem cell products
NewsFDA broadens scope on communication about
unapproved uses to HCPs
NewsU.S. FDA: labeling guidance for sponsors
incorporating prescription drug use-related
softwareNews
FDA concern over misleading DTC promotions
increasing, new guidance suggests
News
FDA proposes mandatory patient labeling for Rxdrugs
NewsFDA proposes mandatory patient labeling for Rx
drugs

compliance problems such as
clinical trials, [and] advertising andpromotion..."LMG Life Sciences