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