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.
Ann counsels clients on FDA and Federal Trade Commission (FTC) regulatory issues associated with OTC drugs, dietary supplements, cosmetics, medical devices, and alternative therapies, as well as US federal, state, and international regulation of FDA-regulated products and activities.
Besides her frequent contacts with the FDA and FTC, Ann’s interactions on behalf of her clients have extended to a range of federal regulators, including the US Drug Enforcement Administration (DEA), the US Patent and Trademark Office, the US Department of Agriculture, the Office for Human Research Protections (OHRP) within the US Department of Health and Human Services, the National Advertising Division of the Council of Better Business Bureaus, and the Association for the Accreditation of Human Research Protector Programs.
Prior to joining Morgan Lewis, Ann was a partner in the food and drug practice of another international law firm, resident in Washington, DC.
Georgetown University, 1986, B.S.N.
Georgetown University Law Center, 1994, J.D., Cum Laude
District of Columbia
U.S. Court of Appeals for the District of Columbia Circuit
Awards and Affiliations
Member, Food and Drug Law Institute
Member, Inova Health Systems Institutional Review Board