Abuse-Deterrent Opioids: Generics Worry Comparator Standard Impedes Approvals
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's draft guidance could make it difficult for generics to show abuse deterrence, especially given 'moving target' of innovator labeling changes, generic firms say.
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.
Abuse-Deterrent Opioids: FDA Advocates Joint Brand-Generic Development Plan
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.