Patient Testimony Highlights Difficulties Of Pain Drug Development, US FDA Regulation Of Opioids
At patient-focused drug development meeting, many patients explained that opioids gave them functionality versus side effects such as suicidal ideation and fatigue that come with other treatments.
You may also be interested in...
Opioid Sponsors Enter 2019 At A Crossroads
Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the
Opioid Policy At US FDA: Over-Promising Or Overreacting?
As President Trump signs SUPPORT Act, former FDA chief counsels offer dueling interpretations of agency's impact in combating opioid crisis.
Opioid REMS Revisions Reflect Some, Not All, Stakeholder Concerns
US FDA's education blueprint now asks sponsors to extend REMS to health providers beyond prescriber, but pain classifications remain unchanged.