June 1, 2018 Source: Ddu 266
Recently, U.S, Food and Drug Administration announced an “innovation challenge” focused to initialize the development of mHealth application and diagnostic tests to detect and prevent the opioid infestation. The FDA challenge is welcoming projects between June and September from the makers with products at any level of development, or with an existing product striving to showcase an improved risk profile compared to opioids for pain management
In November, FDA’s device center will select which app is welcomed into the program, and the selected will have amplified interactions with FDA during the progress of their products. FDA will grant the advanced device nomination to products that meet the permitted criteria without requiring a separate application.
FDA device chief Jeff Shuren said “The FDA stands ready to give significant support and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder”.
In March, The Centers for Disease Control and Prevention said, that drug overdoses eliminated 63,632 Americans in 2016, with 66% of those deaths caused to a prescription or illicit opioid. The surgeon general has said more ppl should carry around naloxone, which can pedal-back the effects of an opioid overdose.
“We’re optimistic in collaborating with public health-minded developers, we can recognize and pump the development of new technologies that can contribute in novel and effective ways to help level-down the scope of this crisis” FDA Commissioner Scott Gottlieb said in a statement.By Ddu
your submission has already been received.
Please enter a valid Email address！
The most relevant industry news & insight will be sent to you every two weeks.