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.
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Abuse-Deterrent Opioids: Where Are They Now?
The potential blockbuster category for abuse-deterrent opioids has fizzled. A few stalwarts are pushing on, but the return on investment for many drug manufacturers has been disappointing. Scrip tracked how opioids approved in the last eight years have performed.
Opioid Litigation: Court Asks US FDA To Attend Education Session
Judge overseeing multidistrict litigation convenes meeting with senior pharma executives, government plaintiffs and others to learn about supply-chain dynamics and other issues to resolve more than 200 suits.
US FDA Monitoring Online Forums For Research Into Opioid Misuse And Abuse
The goal of monitoring Twitter and chat rooms is to proactively identify patterns of misuse and abuse before they fully manifest, Commissioner Gottlieb says.