Partner
Frommer Lawrence & Haug LLP
Washington, DC
(202) 292-1530
Email
Naomi Halpern brings with her approximately 15 years of experience in advising clients on a broad range of regulatory issues involving the Food and Drug Administration (FDA). Her practice focuses on food and drug law and regulatory policy governing pharmaceuticals (including prescription drugs, generic drugs and over-the-counter drugs) and medical devices. Ms. Halpern counsels manufacturers and distributors of these products on issues related to all phases of product development and approval, from the investigational stage to regulatory compliance and post-marketing. She also advises clients with respect to regulatory requirements relating to cosmetics, dietary supplements, and food labeling.
In addition to advising clients on regulatory requirements under the Federal Food, Drug, and Cosmetic Act and related federal and state regulatory statutes, Ms. Halpern represents clients in FDA rulemaking proceedings, and in enforcement proceedings brought by the United States on behalf of the FDA. She has experience in evaluating and advising with respect to marketing strategies for new products, including review and counseling on advertising and promotional materials and strategies. Ms. Halpern also counsels clients on a full range of other regulatory issues relevant to the pharmaceutical, medical device, dietary supplement, and cosmetic industries, including reporting and recordkeeping requirements, clinical trial requirements, import-export issues (including facilitating the entry of FDA-regulated imported products through Customs), recalls and market withdrawals, drug and device listing, and registration, user fees, and orphan therapy issues. She has also worked with industry associations, assisting in the coordination of industry regulatory and legislative strategy as well as contract negotiations and other day-to-day legal issues facing these types of entities. In addition, Ms. Halpern has significant experience with federal and state laws related to medical privacy.
Ms. Halpern graduated with high honors and with distinction from the University of Michigan in 1985, with a Bachelor of Arts in psychology. She received her law degree with honors from George Washington University in 1992, where she was a staff member of The George Washington University Law Review.