Stephanie Resnik is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device, Health Care, and Product Safety practice groups. Her practice focuses on advising pharmaceutical, medical device, biotechnology, tobacco, and children's product companies on a variety of regulatory and compliance issues, including advertising and promotion, fraud and abuse, facility registration, and federal and state reporting requirements. Ms. Resnik also advises pharmaceutical, dietary supplement, and tobacco companies on complying with the requirements of the Federal Hazardous Substances Act, the Consumer Product Safety Act, and the Poison Prevention Packaging Act, including child-resistant packaging requirements for prescription drugs and other FDA-regulated products.
Ms. Resnik has experience counseling clients on interactions with federal and state regulatory agencies, including the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), the Consumer Products Safety Commission (CPSC), and state Boards of Pharmacy.
Ms. Resnik regularly assists clients with preparing public comments for agency rulemakings and guidance documents. She also routinely provides regulatory advice and due diligence to support the corporate transactions of the firm’s life sciences practice.