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Photo of  Kathleen M. Sanzo

practice accolades

FDA

Named the Healthcare Pricing and Reimbursement Firm of the Year by LMG Life Sciences (2013)

Ranked the second-largest U.S. healthcare law firm by Modern Healthcare (2012–2013)

Recognized as a top 10 law firm within the Life Sciences Regulatory Super League by The Practical Law Company (PLC) (2012)

Listed as Recommended in PLC's Life Sciences Multi-Jurisdictional Guide (2012)

honors + affiliations

Vice-Chair, American Bar Association, Section of Administrative Law and Regulatory Practice, Consumer Product Regulation Committee

Member, American Health Lawyers Association

Listed, Best Lawyers in America – FDA Law (2015)

Listed, Thomson Reuters SuperLawyers Washington, D.C.Food and Drugs (2014)

Named U.S. Regulatory Attorney of the Year by LMG Life Sciences (2014)

Named FDA Pharmaceutical Industry Lawyer of the Year by LMG Life Sciences (2013)

Listed as Recommended in Regulatory in the PLC Life Sciences Multi-Jurisdictional Guide (2012)

Listed as Recommended in Regulatory (Medical Devices) in the PLC Life Sciences Multi-Jurisdictional Guide (2012)

Listed as Recommended in Government Enforcement and Investigations in the PLC Life Sciences Multi-Jurisdictional Guide (2012)

Listed, Chambers USA: America's Leading Lawyers for Business (2009–2014)

Listed, International Who's Who of Life Sciences Lawyers 2010

Listed as Recommended in Regulatory in the PLC Life Sciences Multi-Jurisdictional Guide (2012)

Listed, Legal Media Group's Life Sciences "Life Sciences Star" – FDA (2012–2014)

Listed as a Top Lawyer in Food and Drugs, Washingtonian Magazine (Dec. 2011)

Listed, Washingtonian magazine "Best Lawyers" (2013)

bar admissions

  • District of Columbia
print profile

Kathleen M. Sanzo
Partner


Email: ksanzo@morganlewis.com
Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
United States
Phone: +1.202.739.5209
Fax: +1.202.739.3001

Kathleen M. Sanzo is a partner in and leader of Morgan Lewis's FDA Practice. Ms. Sanzo's practice focuses on all regulatory and compliance matters of the Food and Drug Administration relating to prescription and OTC drug and biologic testing, manufacture, approval, marketing, and distribution; pre-clinical and clinical testing; device promotional and labeling issues; food, drug, and device compliance matters; food additive and dietary supplement matters; and food, drug, and device compliance matters of the Consumer Product Safety Commission and related state enforcement agencies.

Ms. Sanzo is vice-chair of the Consumer Product Regulation Committee of the American Bar Association Section of Administrative Law and Regulatory Practice.

Following graduation from Duke University in 1979, Ms. Sanzo received her J.D. from Emory Law School in 1982, and her LL.M. from The George Washington University National Law Center in 1985, where she was selected as the Food and Drug Law Institute Fellow, and worked at the Office of General Counsel of the Food and Drug Administration.

Ms. Sanzo is the author or co-author of numerous publications, including the following: "Prescription, Drug Promotions and Marketing," in FDLI's  Food and Drug Law Regulation 2011, 2nd edition; the FDLI Monograph Series article "Utilizing REMS to Mitigate the Safety Risks of Pharmaceuticals: Perspectives on FDA Guidance, Lifecycle Management and Creating a New Scientific Discipline," November 2010; Washington Legal Foundation article, "The Ever-Widening Legal Morass Around Off-Label Communication," (Contemporary Legal Note Series Number 63), September 2009; "New Risks, New Plan – Drug safety concerns show need for sophisticated risk management," Legal Times, Volume XXX, No 25; "Keys to Successful Interactions with Governing Bodies, Food and Drug Law Settlements and Negotiations," (Aspatore Books), 2006.

Selected speeches include: "Social Media and Medical Device Promotion
What's New?" at the AdvaMed / MTLI Advertising & Promotion of Medical Devices Learning Institute Program in November 2012; "FDA Watch" at the NCCN Academy for Excellence & Leadership in Oncology School of Pharmaceutical & Biotech Business in March 2011; "Regulatory and Legal Considerations on the Use of New Social Media – Twittering on Legal Trends" presented at the AdvaMed's Advertising and Promotion of Medical Devices in an Age of DTC and Social Media marketing Program in March 2011; "Healthcare Reform – New Path for Biosimilars," May 2010; "The Use of Social Media in Promotion of Medical Products," presented at PLI's Health Care  Conference, April 2010; "Legal Issues Arising from REMS Programs," presented at the ACI REMS Conference in New York, 2010.

Ms. Sanzo is admitted to practice in the District of Columbia.

education

  • George Washington University National Law Center, 1985, LL.M.
  • Emory University School of Law, 1982, J.D.
  • Duke University, 1979, A.B.