The Law of Regenerative Medicine and Tissue Engineering
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Features
- Reviews key legal and regulatory challenges presented by the commercialization of cell- and tissue-based products
- Guides the development of strategies for building patent portfolios
- Assists in navigating FDA review for market approval
- Includes extensive references at the end of each chapter to enhance further research
Summary
Numerous clinical trials are currently in progress for complex tissue constructs and cell therapies. Many companies are commercializing skin substitutes, expanded cell populations for cartilage repair, and extracellular materials intended to enable remodeling or repair at the implementation site. This book provides an overview of legal and regulatory elements that can significantly impact the clinical introduction of cell- and tissue-based products. As a reference for important regulations at both the federal and state level, it guides the development of strategies for building patent portfolios and navigating FDA review for market approval.
Table of Contents
Introduction: An Overview of the Emerging Legal Regime Governing Regenerative Medicine. Ownership, Transfer and Use of Cell- and Tissue-Based Materials. Intellectual Property. FDA Regulation of Tissue Engineered Medical Products (TEMPs). Reimbursement for Cell- and Tissue-Based Products and Therapies. Liability Issues. Postscript: Trends in Legislation, Regulation and Case Law for the Future of Regenerative Medicine. Reference Materials: Relevant Federal and State Statutes and Regulations. Footnotes.
