Generics Of Abuse-Deterrent Opioids Will Get FDA Guidance, Eventually
Executive Summary
FDA is developing a step-wise approach for developers of generic versions of opioids with an abuse-deterrence claim, but first it needs the results of two research projects.
You may also be interested in...
Final Generic Abuse-Deterrent Opioids Guidance Coming This Year
US FDA says it expects to finalize guidance by November, but more research is needed with generic development questions lingering.
Final Generic Abuse-Deterrent Opioids Guidance Coming This Year
US FDA says it expects to finalize guidance by November, but more research is needed with generic development questions lingering.
FDA In Twilight: Gov’t Shutdown Has Not Slowed Rx Operations Too Visibly Yet
Shutdown puts API shipments on a slow boat, but reviews of existing products can proceed with carry-over funds, even as new applications cannot be filed. CDC has largely halted its influenza program and NIH has ceased enrolling new patients in its clinical center.