Kristen Klesh is counsel in Venable's Regulatory Practice, where she advises clients on a range of FDA and FTC regulatory matters, including promotional and marketing practices, manufacturing compliance, and regulation of clinical research. With respect to advertising and marketing of cosmetics, foods, and dietary supplements, Kristen has experience evaluating claim substantiation under NAD decisions and FTC rules. She has also advised dietary supplement companies in developing labeling claims, including "structure/function" claims and health claims, and has experience assisting cosmetic and drug companies with FDA's Over-the-Counter (OTC) Drug Monograph requirements.
Kristen also has experience assisting a wide range of drug, device, and dietary supplement companies in compliance matters related to FDA’s good manufacturing practices (GMP) requirements, including helping to perform GMP compliance audits on behalf of clients.
With respect to medical devices, she has assisted clients in obtaining 510(k) clearance for a medical device, evaluating their roles and responsibilities under FDA’s Quality System Regulation, and has significant experience in compliance matters related to FDA’s medical device reporting (MDR) requirements.