FDA and generic drug manufacturers kick off formal negotiations on the next cycle of the Generic Drug User Fee Amendments during a recent meeting at the agency’s White Oak campus, which saw both parties offer several operating proposals.
Bristol Myers Squibb (BMS) and Johnson & Johnson stop their Phase 3 Librexia ACS trial of the investigational anticoagulant milvexian after an independent monitoring committee concluded the study was unlikely to meet its primary endpoint.
FDA and generic drug manufacturers kick off formal negotiations on the next cycle of the Generic Drug User Fee Amendments during a recent meeting at the agency’s White Oak campus, which saw both parties offer several operating proposals.
Bristol Myers Squibb (BMS) and Johnson & Johnson stop their Phase 3 Librexia ACS trial of the investigational anticoagulant milvexian after an independent monitoring committee concluded the study was unlikely to meet its primary endpoint.
FDA commissioner Marty Makary and CBER director Vinay Prasad preview upcoming agency reforms during an FDA Direct podcast focused on the appointment of longtime oncology regulator Rick Pazdur as CDER’s new director.
An Axios report examines growing criticism of recent FDA actions that are fueling uncertainty among drug developers and weakening public confidence in the agency.
