Jessica Ritsick counsels clients that design, manufacture, sell, and distribute drugs, biologics, medical devices, food, and other FDA-regulated products. Jess draws on her experience working in the FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Human Foods Program (HFP), and her collaborations across the agency and federal government, to help advise on FDA policies and guidance and advise on compliance issues related to current good manufacturing practice (CGMP) violations, medical device shortages and cybersecurity, and the Drug Supply Chain Security Act (DSCSA).
Before joining Alston & Bird, Jess most recently served as regulatory counsel in the HFP’s Office of Policy, Regulations, and Information. Jess previously served as senior regulatory counsel in the CDRH’s Office of Policy, where she advised on a variety of complex and high-profile regulatory and compliance matters, including serving on the COVID-19 pandemic response team, where she drafted and evaluated emergency use authorizations. Jess also served as regulatory counsel in CDER’s Office of Compliance in the Office of Manufacturing Quality and the Office of Drug Security, Integrity, and Response. Before joining the FDA, Jess was in private practice and also served as a law clerk to the senior judges at the District of Columbia Court of Appeals.