Kathleen M. Sanzo

As the FDA practice leader, Kathleen represents clients in the pharmaceuticals and biotechnology, food and dietary supplements, consumer products, consumer protection safety, advertising, cosmetics, drugs, and medical industries.

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.”

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.

• Counseling emerging biotech companies relating to product pathway status (e.g., NDA vs. 505(b)(2)s, Orphan status, fast track, etc.)
• Counseling startup company on response to Complete Response Letters
• Counseling a major pharmaceutical company on a global cGMP 483 response and resulting audit
• Counseling a major pharmaceutical company on supply chain controls and audits
• Providing day-to-day advising on product marketing and promotion materials, including social media
• Assisting in regulatory due diligence of pharmaceutical company mergers and acquisitions
• Counseling on various food and cosmetic related issues on claims and investigations of claims, by federal, state, NAD authorities
• Counseling consumer product companies on submission of Section 15(b) notices, CPSC penalty investigations, and compliance with testing and GCC requirements