Jessica Tierney has over 10 years of experience working with U.S. Food & Drug Administration (FDA) regulations and enforcement activities. As a former attorney with the FDA, Jessica brings valuable perspective to clients seeking advice in matters before the agency.
Jessica regularly advises clients on bringing to market novel food, tobacco, medical device, and drug products. Clients frequently look to Jessica when engaging with the FDA, particularly in matters involving regulatory compliance such as recalls and withdrawals, responses to FDA 483 violation forms and warning letters, and matters regarding marketing and good manufacturing practices.
Prior to joining Jones Day in 2022, Jessica worked at a Washington, D.C.-based law firm. Before that, she held senior positions within the FDA's Center for Tobacco Products and the Center for Drug Evaluation and Research, where she developed regulations, guidance, drafted responses to citizen petitions, advised key stakeholders on the Federal Food, Drug, and Cosmetic (FD&C) Act, and provided consultation on labeling disputes. Her vast regulatory experience encompasses developing solutions for complex regulatory matters and initiating policy related to public health.
Experiência
- The Catholic University of America (J.D. 2011); Boston College (B.A. 2001)
- Virginia, District of Columbia, and U.S. Courts of Appeals for the Second, Fourth, Fifth, and Ninth Circuits
- Served with the U.S. Food & Drug Administration (2011-2021) in the following positions: Regulatory Counsel, Office of Regulatory Policy, Center for Drug Evaluation and Research (2020-2021) and Branch Chief, Office of Compliance and Enforcement, Center for Tobacco Products (CTP) (2011-2020)