Kathleen M. Sanzo

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.

• Emerging biotech companies relating to product pathway status (e.g., NDA vs. 505(b)(2)s, Orphan status, fast track, etc.)
• A startup company on response to Complete Response Letters
• A major pharmaceutical company on a global cGMP 483 response and resulting audit
• A major pharmaceutical company on supply chain controls and audits
• A major research entity on investigation of CRO and clinical trial deficiencies
• A startup biopharmaceutical company on the regulatory and commercial issues in the manufacture of cell therapies
• Multiple storage companies concerning the regulatory requirements for cell and tissue-based products
• A startup OTC and dietary supplement company with innovative delivery of products
• A major dietary supplement company concerning manufacturing and product claims and false advertising litigation
• A global company in negotiation of an FTC concern decree on dietary supplement and medical food products
• A global company in settlement of multiple investigations concerning defect reporting to CPSC