Quality of Life Claims, Marketing and the FDA: Creating a Competitive Advantage in a Crowded Market

September 2007
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This management report from Value of Insight (VOI) Consulting, Inc. and FDAnews maps out what’s required to pass muster with CDER and DDMAC — and how to avoid extra trial costs by building in QoL data-gathering right from the start.

By combining exclusive surveys with real-world guidance, Quality of Life Claims, Marketing and the FDA helps you zero in on your own best strategy. Plus, you’ll learn how companies have used QoL claims and marketing to turn pipelines from lackluster to blockbuster.

Order today to discover:

  • Why expiring patents and slowing pipelines make QoL a vital strategy
  • What it takes to win approval from the FDA/DDMAC
  • How to articulate QoL claims that differentiate your product without courting warning letters
  • How to avoid common missteps (like “implied QoL” claims) before approval — and after
  • Best-bet products and categories for pursuing QoL claims
  • How to design low-cost elements to capture data necessary to make QoL claims
  • Real-world practices for using QoL claims and marketing to stay visible — and profitable — as competition and price pressures continue to intensify

Meet Your Expert Author
Todd Clark, president of Value of Insight (VOI) Consulting, Inc., has 15 years experience in the pharmaceutical industry focusing on the intersection between regulation, marketing and economics. Todd is the author of PharmaHandbook — A Guide to the International Pharmaceutical Industry, the first-ever single source reference guide on the pharmaceutical business and regulatory environments in 39 countries and GenericHandbook — A Guide to the US Generic Pharmaceutical Industry, a comprehensive reference guide to the marketing, intellectual property, legal, regulatory and competitive aspects of the generic drug sector in the U.S.

Todd is a graduate of Tulane University and has an MBA with majors in finance, management strategy and marketing from the Kellogg School of Management at Northwestern University. He is an adjunct professor at Tulane University and Loyola University, New Orleans and teaches courses in business strategy, marketing and managerial decisionmaking.

Buy Now!
Don’t wait! Quality of Life Claims, Marketing and the FDA shows you what to do today to integrate thesetactics — for a competitive edge worth millions and millions of dollars for years to come. Available in print or PDF format for $337 each.

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