Keeping Track: A Lilly Breast Cancer Approval, A Couple Of CRLs, And A Plethora Of Priority Reviews
The latest drug development news and highlights from our Performance Tracker.
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Drug Rejection Hearings Are Having A Moment At US FDA
With Intarcia's request, the rarely used mechanism could now produce two hearings this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.
Intellipharmaceutics’ Oxycodone ER Returns To US FDA Panel Looking For Abuse-Deterrence Claim
Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.
Keeping Track: Industry Beefs Up 2020 Review Pipeline With Submissions Galore
The latest drug development news and highlights from our US FDA Performance Tracker.