FDA announces new policy for the development of regenerative medicines
Today, the U.S. Food and Drug Administration released a comprehensive framework for the development and supervision of regenerative medicines products, including new cellular therapies.
The framework, outlined in four guidance documents, builds on the FDA’s existing approach to risk-based regulation, which aims to clarify what products are classified as drugs, medical devices and/or biologic products. Two of the four guidance documents also propose a science-based, efficient process to help ensure the safety, effectiveness, and development of these therapies. The FDA’s suite of documents defines a framework based on risk that will guide its enforcement against products with significant safety concerns. This framework is designed to strike a balance between the FDA’s commitment towards safety and mechanisms that will drive further advancements in regenerative medicines so innovators can deliver new, effective therapies as quickly as possible to patients. This policy is also in line with important provisions of 21st Century Cures Act.
The promise of a new paradigm in medicine is that we can facilitate the regeneration of human organs. Cells and tissues can then be engineered to produce healthy, functional replacements for diseased organs. New genes can also be introduced to the body to fight disease. Adult stem cells can replace cells lost due to injury or illness. Science fiction is not possible anymore. Modern applications of regenerative medicines offer a practical solution.