Abuse-Deterrent Opioids: FDA Advocates Joint Brand-Generic Development Plan
Executive Summary
Despite ‘tension’ between two industries over what is required to show generic is no less abuse-deterrent than innovator opioid, FDA’s Throckmorton suggests they come up with single approach to product development.
You may also be interested in...
Generic Abuse-Deterrent Opioids: Comparison To Brand Will Not Require Use Of Control
FDA final guidance recommends comparative pharmacodynamic studies for nasal and oral routes of abuse, simplifies statistical approach to show deterrence of generic is same as brand.
Generic Abuse-Deterrent Opioids: Comparison To Brand Will Not Require Use Of Control
FDA final guidance recommends comparative pharmacodynamic studies for nasal and oral routes of abuse, simplifies statistical approach to show deterrence of generic is same as brand.
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.