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In its second move this week to tackle the growing opioid epidemic, the FDA is outlining what tests sponsors of abuse-deterrent generic opioids should submit. Read More
The FDA’s plans to create a pilot database of clinical outcome assessments lacks the depth and breadth of data needed to make it worthwhile, according to comments from industry and advocacy groups. Read More
Participation in biosimilar development program activities with the FDA has seen a steady uptick over the past three fiscal years — from 33 in fiscal 2013, to 57 last year — according to an analysis by independent consulting firm Eastern Research Group. Read More
The average cost of developing a new drug continues to rise, even as approval success rates continue to fall, according to a report that pegs the cost of ushering a candidate through FDA approval at an eye-popping $2.6 billion. Read More