CHI Responds To FDA Medical Device Innovation Initiative
CHI-California Healthcare Institute issued the following response today to the U.S. Food and Drug Administration's (FDA) "Medical Device Innovation Initiative:" "CHI commends the FDA for its recognition of the need for a more efficient regulatory pathway for innovative medical devices that have the potential to improve lives," said CHI President and CEO David L. Gollaher, Ph.D. "It is essential ...

Should Patients Have A Voice In FDA Drug Approvals?
People suffering from rare or chronic diseases often have to wait years for new drugs to get through the complicated regulatory process in the US. But, putting prescription drugs on the market too soon can put patients at risk. On our monthly segment on ethics in science and technology, we'll talk about the ethics of giving patients more of a voice in the regulatory decision-making process.

FDA Creates "Innovation Pathway" For Robotic, Brain Controlled Appendage
The FDA this week has proposed a new Innovation Pathway program that will enable the approval process of new groundbreaking technologies be expedited more rapidly and delivered to the public for use in the field. The first submission is a brain-controlled, upper-extremity prosthetic. The program seeks to quickly identify and nurture technology that has the potential to transform medical care and ...