Vericel Corp. (VCEL)

[commoncentsinvestor]

FDA Commissioner Scott Gottlieb: "In addition, the FDA will continue to work closely with industry to find other ways to aid in the effort to bring novel therapies to patients as quickly, and as safely, as possible. One of these will include our continued commitment to fully implement the Regenerative Medicine Advanced Therapy (RMAT) designation. This pathway enables regenerative cell therapies to access the FDA’s existing expedited programs to help foster the development and approval of these novel products. Among other things, we plan to include certain gene therapy products that permanently alter tissue and produce a sustained therapeutic benefit as part of the products that will meet the definition of being eligible to come under the pathway enabled by RMAT. This is part of our broader commitment to pursue efforts that will advance innovation in this space. We encourage sponsors who are seeking FDA approval of their product to consider this pathway."

http://www.oasissurg.com/2017/08/28/fda-commissioner-scott-gottlieb-m-d-on-fdas-new-policy-steps-and-enforcement-efforts-of-stem-cell-therapies-and-regenerative-medicine/