Industry Needs To Submit Fewer Safety Reports, US FDA Official Says
Only 14% of expedited reports sent to FDA's oncology office were informative, CDER's Jarow says, arguing that sponsors 'pull the fire alarm' too frequently.
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CDER Director Woodcock announced that the drug center will soon launch the Drug Risk Management Board, which will coordinate product safety activities among the different offices; Patrizia Cavazzoni, who serves as CDER's deputy director of operations, will chair the board.
The latest drug development news and highlights from our US FDA Performance Tracker.
But more data on abuse potential and efficacy could offer path for forward for oxycodegol even after the FDA product-specific advisory committee meeting for an opioid analgesic in more than a year goes very badly for the sponsor.