ARTICLE | Regulation

Growth medium

How FDA’s regenerative medicine framework puts the U.S., Japan and Europe on the same page

December 16, 2017 12:52 AM UTC

FDA’s regenerative medicines framework could level the global regulatory playing field for products like cell and gene therapies. It describes approaches to implementing expedited development and review pathways that make them comparable, and in some ways more attractive than those available in Japan and Europe.

The framework, released in November, reflects commitments from FDA Commissioner Scott Gottlieb and the agency’s senior career staff to promote technologies they believe can transform the treatment of many intractable diseases and conditions. ...