Kathleen Sanzo

Partner @Morgan, Lewis & Bockius LLP

Washington, DC, US

As the FDA & Healthcare practice leader, Kathleen Sanzo represents clients in the pharmaceuticals and biotechnology, food and dietary supplements, consumer products, consumer protection safety, advertising, cosmetics, drugs, and medical industries. Kathleen centers her practice on regulatory and compliance issues connected to products regulated by the US Food and Drug Administration (FDA). She leads and counsels clients on matters relating to prescription, OTC drug, and biotechnology products clinical testing; food, dietary supplement, and cosmetic product manufacture, approval, marketing, and distribution; device promotion and labeling issues; food, drug, and device compliance matters; and all consumer product issues regulated by the US Consumer Product Safety Commission (CPSC) and state enforcement agencies.Kathleen advises companies on regulatory pathway strategies, appropriate responses to FDA protocols and complete response letters, dispute resolution, responding to Current Good Manufacturing Practice (cGMP) issues, including 483s and Warning Letters, as well as day to day counseling on marketing and promotion launch and other communications, including responses to FDA Untitled and Warning Letters; and similar advice and counsel on food, dietary supplements, and cosmetic products, including various notices and registrations to FDA; recalls and other crisis management; and counseling on product testing, Section 15(b) notices and penalty investigations, as well as product recalls. A frequent author and co-author on publications related to FDA matters, Kathleen regularly speaks on these issues at industry events. Industry and legal groups have praised her work: Legal Media Group Life Sciences named her the “US Regulatory Attorney of the Year,” “FDA Pharmaceutical Industry Lawyer of the Year,” and a “Life Sciences Star.” Chambers USA have listed her in “America’s Leading Lawyers for Business.”

Duke University

AB, Political Science

George Washington University National Law Center

LLM, Administrative Law: Economic Regulation

Emory University School of Law

JD, Law