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Promotion of FDA-Regulated Medical Products

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Promotion of FDA-Regulated Medical Products
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Authors: Joanne S. Hawana, MS, JD, Bethany J. Hills, MPH, JD and Benjamin M. Zegarelli, MS, JD

This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices. Its 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. 

Who Should Buy This Book?

Anyone involved in developing promotional and advertising plans for new prescription medical products would benefit from the information in this book, not just regulatory personnel, but marketing and legal teams as well as management. 

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