Kathleen M. Sanzo 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.
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.
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
Duke University, 1979, A.B.
Emory University School of Law, 1982, J.D.
The George Washington University Law School, 1985, LL.M.
District of Columbia
Awards and Affiliations
Ranked, Life Sciences: Regulatory/Compliance, Nationwide, Chambers USA (2018)
Ranked, Healthcare: Pharmaceutical/Medical Products Regulatory, District of Columbia, Chambers USA (2018)
Vice-Chair, American Bar Association, Section of Administrative Law and Regulatory Practice, Consumer Product Regulation Committee
Member, American Health Lawyers Association
Member, Law360 Life Sciences Editorial Advisory Board (2016)
Recognized, FDA Law, Best Lawyers in America (2015–2018)
Top Woman Lawyer, Best Lawyers (2016, 2017)
Recognized, Life Sciences–Regulatory, Who’s Who Legal (2015–2018)
Recognized, Food and Drugs, SuperLawyers Washington, DC (2014–2015)
US Regulatory Attorney of the Year, LMG Life Sciences (2014)
FDA Pharmaceutical Industry Lawyer of the Year, LMG Life Sciences (2013)
Recognized, FDA & Pharmaceutical in the PLC Life Sciences Multi-Jurisdictional Guide (2015)
Recognized, Regulatory in the PLC Life Sciences Multi-Jurisdictional Guide (2012)
Recognized, Regulatory (Medical Devices) in the PLCLife Sciences Multi-Jurisdictional Guide (2012)
Recognized, Government Enforcement and Investigations in the PLCLife Sciences Multi-Jurisdictional Guide (2012)
Ranked, Chambers USA: America's Leading Lawyers for Business (2009–2017)
Recommended, Industry Focus - Healthcare - Life Sciences, The Legal 500 US (2017, 2018)
Named, International Who's Who of Life Sciences Lawyers 2010
Life Sciences Star, LMG Life Sciences Guide – FDA (2012–2015); Regulatory (2016–2017)
Top Lawyers: Food and Drug, Washingtonian Magazine (2011–2014)
Best Lawyers in Washington, DC – FDA Law, Washingtonian Magazine (2011–2015)