Law firm Sheppard breaks down some of FDA’s proposals in its budget documents that industry should keep a close eye on, including new DTC ad authorities that signal enforcement will likely intensify under this administration.
A Clinical Trial Vanguard online column explains how a 2022 FDA master protocol guidance has not kept pace with non-oncology basket trial developments.
Law firm Sheppard breaks down some of FDA’s proposals in its budget documents that industry should keep a close eye on, including new DTC ad authorities that signal enforcement will likely intensify under this administration.
A Clinical Trial Vanguard online column explains how a 2022 FDA master protocol guidance has not kept pace with non-oncology basket trial developments.
An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage.
Insmed discontinues development of its drug candidate brensocatib for hidradenitis suppurativa after a mid-stage clinical trial failed to meet its primary and secondary efficacy endpoints.
