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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.