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Combination Products: How to Develop the Optimal Strategic Path for Approval

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April 2005

Here's an essential guide for manufacturers seeking FDA approval of groundbreaking new medical products and therapies that combine drug, device or biologic therapies. When is the right time to consult the agency? What should you ask for, and how should you ask? What's the best way to present your data? How do you take control of the regulatory process for speedy, hassle-free approvals? Combination Products: How to Develop the Optimal Strategic Path for Approval provides the answers — and a strategic roadmap to approval of your most innovative products and therapies based on drug, device or biologic combinations.

Meet the Authors
David M. Fox, Esq. spent more than six years as FDA assistant chief counsel for enforcement and associate chief counsel for drugs. He was counsel to the FDA ombudsman on combination products and jurisdictional issues. He is now in private practice in the Washington office of Hogan & Hartson LLP, where he represents manufacturers of combination products. He is in demand as a speaker on regulation of combination products.

Jeffrey K. Shapiro, Esq., is a partner with Hogan & Hartson LLP in the firm's FDA practice group. His practice focuses primarily on helping medical device and diagnostic companies comply with FDA regulatory requirements, including significant experience in combination product and product jurisdiction matters. He is the author of many articles in the trade press and is a frequent speaker at medical device and diagnostic seminars and conferences.

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