KATHLEEN SANZO is the leader of the Morgan Lewis FDA practice and co-chair of the firm’s life sciences industry group. Kathleen centers her practice on regulatory and compliance issues connected to FDA regulated products. She leads and counsels clients on all legal and regulatory issues concerning product development and testing, manufacturing and marketing of prescription, OTC drug, biologic and vaccine products, and orphan drugs; food, dietary supplements, and cosmetic product manufacture, approval, marketing, and distribution; food, drug, and device compliance and enforcement matters; and 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) inspections and deficiencies, including 483s and Warning Letters, as well as day-to-day counseling on marketing and promotion launch, social media, and similar 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 consumer product standards and 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 has listed her in “America’s Leading Lawyers for Business.”

Kathleen serves as vice-chair of the Consumer Product Regulation Committee of the American Bar Association Section of Administrative Law and Regulatory Practice, and is a member of the Food and Drug Law Institute’s Medical Products Committee.
She is a board member of INMED Partnerships for Children.