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Mr. Shapiro has represented health care companies on FDA-related matters since 1994. He advises companies on a wide variety of issues in the areas of medical devices, combination products, and human tissue products, including product approvals, marketing, clinical studies, jurisdictional issues, and enforcement.
Mr. Shapiro has written and lectured extensively on a variety of FDA-related topics. He is the co-editor of Promotion of Biomedical Products, a textbook on the FDA's regulation of promotion and advertising published in 2006 by the Food and Drug Law Institute (FDLI); he authored two chapters of this textbook. Mr. Shapiro is also the co-author of the book, Combination Products: How to Develop the Optimal Strategic Path for Approval (FDA News 2005), available at www.fdanews.com.
Mr. Shapiro has authored numerous articles on FDA regulatory topics in publications such as Medical Device and Diagnostic Industry (MDDI), the Food and Drug Law Journal, Regulatory Affairs Focus, and the Food and Drug Law Institute's (FDLI) Update. Mr. Shapiro is on the Editorial Advisory Board of MDDI and Update magazines. He is also a frequent speaker at medical device and diagnostic seminars and conferences.
Prior to joining this firm, he was a partner in the FDA practice group at Hogan & Hartson. Mr. Shapiro is a graduate of Brown University (1983 magna cum laude) and the Harvard Law School (1986 cum laude). He is admitted to practice law in the District of Columbia, California and Pennsylvania.
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