Given the staggering cost of developing FDA-regulated products, launching and promoting these products effectively — in compliance with FDA guidelines — is key to achieving commercial success and avoiding costly enforcement action.
In “Promotion of FDA-Regulated Medical Products,” a book published by the Regulatory Affairs Professionals Society (RAPS), Mintz attorneys Bethany Hills, Joanne Hawana, and Benjamin Zegarelli have applied their FDA expertise and business insight to create a thorough and practical guide for professionals involved in developing promotional and advertising plans for new prescription medical products.
The book’s seven chapters are divided into three parts. Part I, Fundamentals, introduces the agencies involved in prescription drug and device labeling, reviews the fundamental prescription drug and device labeling and promotion principles and labeling and promotion of these products prior to approval and for off-label use. Part II, Communications to Certain Audiences, discusses the differences in messaging for healthcare professionals, consumers and more sophisticated audiences. Practical Advice for Regulatory Professionals, Part III, examines additional promotional regulatory and legal considerations.
As Chair of Mintz’s FDA practice, Ms. Hills leverages deep FDA regulatory experience and exceptional knowledge of the health care delivery system to help international and domestic life science and health technology companies enter and navigate the U.S. health care market. She advises life science companies and investors in a broad range of regulatory, reimbursement, and U.S. and international compliance matters.
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.
Mr. Zegarelli advises clients on federal and state laws surrounding manufacturer product development and marketing. He participates in the coordination of diligence reviews in transactions involving large pharmaceutical and medical device manufacturers. Mr. Zegarelli has assisted with the development of policy positions and the submission of comments to the FDA with the analysis and drafting of 510(k) applications for submission to the FDA.
Mintz’s market-leading FDA practice continues to build upon the capabilities they offer clients in the space. The team recently added FDA Senior Policy Advisor Aaron L. Josephson as a Senior Director of ML Strategies, a wholly-owned consulting subsidiary of Mintz, to advise clients on health care policy issues related to medical devices and pharmaceuticals. Earlier, he spent 10 years with the US Food and Drug Administration, most recently as a senior policy advisor in the Center for Devices and Radiological Health where he led legislative policy development activities related to all aspects of medical device regulation and oversight.
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