A UCSF-led effort to create an implantable artificial kidney for dialysis patients has been selected as one of the first projects to undergo more timely and collaborative review at the Food and Drug Administration.
The FDA announced today (April 9) that it had chosen three renal device projects to pilot a new regulatory approval program called Innovation Pathway 2.0, intended to bring breakthrough medical device technologies to patients faster and more efficiently.
The artificial kidney project, which is targeted for clinical trials in 2017, was selected for its transformative potential in treating end stage renal disease and for its potential to benefit from early interactions with the FDA in the approval process.
The FDA effort will involve close contact between the federal agency and device developers early in the development process to identify and address potential scientific and regulatory hurdles and create a roadmap for project approval. The goal is to improve the projects' overall chance of success, while reducing the time and cost of FDA review and maintaining safety. Lessons, the agency said, will inform approvals in other areas.
The artificial kidney project has brought together 40 researchers in nine laboratories nationwide under the guidance of Shuvo Roy, PhD, a bioengineer on the faculty of the UCSF School of Pharmacy. It aims to combine nano-scale engineering with the most recent advances in cellular biology to create an implantable device that would enable patients with chronic kidney failure to lead healthier and more productive lives, without external dialysis or immune suppressant medication.
"The new Pathway program is a clear signal to researchers that innovations in how we treat disease are needed and supported by the FDA," said Mary Anne Koda-Kimble, PharmD, dean of the UCSF School of Pharmacy. "We're so pleased the Kidney Project is in the vanguard as the program launches."
|Contact: Kristen Bole|
University of California - San Francisco