Patent and regulatory issues of hydrogel for tissue engineering and regenerative medicine

In the last three decades, the field of tissue engineering and regenerative medicines have benefited significantly with the introduction of hydrogel technologies. Hydrogel products have particularly gained popularity due to their ability to create a distinct three-dimensional structure, provide mechanical support for the cells in the engineered tissues, and simulate the native extracellular matrix. The first part of this book chapter covers the issues pertaining to the regulation of hydrogel products in tissue engineering and regenerative medicine application with specific reference to the United States of Food and Drug Administration. The second part covers the patent landscape of hydrogel in tissue regeneration using the text-mining approach to scrutinize patents of hydrogel in tissue regeneration in various clusters.