Ann M. Begley advises clients on a range of US Food and Drug Administration (FDA) legal and regulatory issues relating to drug, cosmetic, dietary supplement, food, and medical device products, with an emphasis on matters involving clinical practice and over-the-counter (OTC) drugs. Ann counsels institutional review boards, clinical investigators, and sponsors on compliance and strategic issues. She also provides extensive guidance on product approval pathways, formulation, labeling, and product advertising.