Regenerative medicine: Analysis, forecast and regulatory requirements

Abstract

Regenerative medicine is a new and expanding field in biomedical research. Organ and tissue loss through disease and injury, propel the development of a treatment that can regenerate tissue and help for less relaying in organ transplantation. Regenerative medicine has the potential to heal tissue and damaged organ. Currently, a patient suffering from diseased and injured organs can be treated with transplantation organs, but there is a shortage of donor organs. Dermatology is estimated to have a larger share in the market for regenerative medicine as skin being an organ with great cell replicate characteristics. US and Japan play a major role in the market for regenerative medicine. Food and drug administration (FDA) regulations for a medical device used in regenerative medicine are covered here to support risk-based, flexible regulatory methods to help and support the potential to bring novel treatment possibilities to market further. But due to incorrect FDA regulations, it stands as a barrier for the marketing regenerative medicines. Better and clear guidance development or a clear regulatory framework for both regenerative medicine and medical device can leads the product a best fit clinical development and product access in the market.