Innovation Pathway Advances May Be Expanded Throughout Agency

CINCINNATI — Regulatory advances made during the Innovation Pathway 2.0 project to develop new treatments for end-stage renal disease may quickly be rolled throughout CDRH, center Director Jeffrey Shuren said Wednesday at the FDA/Xavier University MedCon Conference here. Innovation Pathway is designed to help speed breakthrough technologies to market through greater work with devicemakers and the use of outside experts, including entrepreneurs. Phase two, focusing on the development of four treatments for end-stage renal disease, was announced last month.
Devices & Diagnostics Letter