Jennifer Davidson is a partner who joined the firm in 1999. She represents large, small, and start-up companies on a wide range of FDA-related matters. She has counseled members of the pharmaceutical, dietary supplement, cosmetic, food, and medical device industries on a variety of legal and regulatory matters involving the FDA and related State and Federal agencies.
In recent years, Ms. Davidson has advised pharmaceutical clients on promotional and marketing practices, other post-approval requirements, life-cycle management, exclusivity questions, user fees, and issues arising under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act, as well as those introduced by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the Food and Drug Administration Amendments Act of 2007. A significant component of her practice involves assisting clients in presenting complex issues to FDA via the agency’s Citizen Petition procedures. Ms. Davidson also has experience representing industry in registration and scheduling proceedings before the Drug Enforcement Administration.
Her practice also includes counseling companies on all aspects of promoting and marketing OTC drug products, medical devices, foods, and cosmetics, including product labeling. With respect to dietary supplements, Ms. Davidson has advised clients on the requirements of the Dietary Supplement Health and Education Act of 1994, including product labeling, determining whether a product satisfies the definition of dietary supplement, evaluating whether a new dietary ingredient notification is required, and identifying the types of claims that may be made in labeling and advertising.
Ms. Davidson also advises companies on a range of related issues associated with the development of advertising and labeling claims, including the adequacy of substantiation, the express and implied claims conveyed by promotional messages, and the evaluation of consumer perception surveys. She has assisted clients in defending and initiating challenges against competitors’ labeling and marketing practices before the FDA and in related private disputes under the Lanham Act and before the National Advertising Division of the Council of Better Business Bureaus, Inc., and related entities, such as the Children’s Advertising Review Unit and the Electronic Retailing Self-Regulation Program. Ms. Davidson also assists clients in obtaining appropriate network clearance to air advertising on television. Her practice also involves civil litigation against the FDA on behalf of regulated industry.
Before joining Kleinfeld, Kaplan and Becker LLP, Ms. Davidson practiced in the Washington D.C. office of a large, international law firm, specializing in civil litigation.
Best Lawyers in America (FDA Law) 2015-2019