Recent advances in science and technology have created unlimited potential for how medical treatments will be developed and used. But to truly realize this potential, we must act now— not only for the health of our nation's public, but for a critical piece of the economy as well.
This document is a blueprint stemming from extensive engagement with all of the major stakeholders—from leaders in industry to academic researchers to small businesses to patients. While it outlines immediate steps that FDA will take as an Agency to adapt to the changing landscape and drive American biomedical innovation forward, it is just a starting point.
As an agency, FDA will continue to engage the biomedical community to assess and reassess the ecosystem and identify additional areas for improvement. The future of medical treatment is full of opportunities for patients and industry alike, and the steps outlined in this document will position FDA to be an important driving force in quickly getting the safest and most effective treatments to market to help protect the public health.