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Mintz Bolsters FDA Capabilities with Addition of Joanne S. Hawana

Mintz, Cohn, Ferris, Glovsky and Popeo, P.C. is expanding its Health Law Practice with the addition of Joanne S. Hawana. Formerly a member of Arent Fox’s Food & Drug Practice, Ms. Hawana joins as Of Counsel based in Washington, D.C.

Ms. Hawana represents clients around the world in the food, drug, and biotechnology industries on issues ranging from prescription drug advertising to state licensing requirements for wholesale distribution. In particular, she advises on the business impact of new U.S. federal and state actions that affect regulated products, such as drugs, foods, and medical devices. Ms. Hawana also counsels clients with regulated products on the implications of new business ventures or supply chain modifications, as well as on requirements for importing their products into the United States. For biotechnology-derived products, she advises on complying with applicable FDA, EPA, and USDA regulations.

“Joanne’s background and broad experience will further enhance our ability to counsel clients on FDA and other regulatory matters,” said Karen S. Lovitch, who leads the firm’s Health Law Practice. “We are delighted to welcome her to the firm.”

Ms. Hawana is experienced in U.S. federal drug regulations, including pre-market and post-market requirements, and restrictions on advertising and sampling. She is well versed in advising clients on the regulatory considerations for marketing controlled substances, track-and-trace systems for prescription drugs, and the food safety and labeling requirements for human and animal food. Ms. Hawana also has counseled both pharmacies and practitioners on drug compounding regulatory matters. In addition, she has worked with manufacturers and retailers to determine the regulatory status of certain medical devices, laboratory tests, and mobile medical applications.

Ms. Hawana received her J.D., cum laude, from the University of Maryland. She also holds a M.S. in Molecular Genetics and Microbiology from the University of Medicine and Dentistry of New Jersey and a B.S in Biology from the College of William & Mary. 

Attorneys in Mintz Health Law Practice, many of whom have held senior government positions or served as in-house counsel, represent for-profit and non-profit, domestic and international companies in connection with a wide variety of business and legal transactions, challenges and issues that they confront both on a daily basis and in bet-the-company matters. Clients span the full spectrum of the industry, including hospital systems, managed care organizations, laboratories, long-term care providers, durable medical equipment suppliers, behavioral health companies, pharmaceutical and medical device manufacturers, retail pharmacies and pharmacy benefit managers.