Kristen Klesh advises clients on a range of Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulatory matters. Kristen’s experience includes promotional and marketing practices, manufacturing compliance, and regulation of clinical research. She has experience with regulations involving advertising and marketing of cosmetics, foods, and dietary supplements. Kristen evaluates claim substantiation under National Advertising Division (NAD) decisions and FTC rules. She has advised dietary supplement companies in developing labeling claims, including “structure/function” claims and health claims, and has assisted cosmetic and drug companies with the FDA's Over-the-Counter (OTC) drug monograph requirements.
Kristen has assisted a wide range of drug, device, and dietary supplement companies with compliance matters related to the FDA’s good manufacturing practices (GMP) requirements, including helping to perform GMP compliance audits on behalf of clients. She also has assisted clients in obtaining 510(k) clearance for a medical device, and evaluating client roles and responsibilities under the FDA’s Quality System Regulation. She has significant experience in compliance matters related to the FDA’s medical device reporting (MDR) requirements.