Is biopharma getting better at accelerated approval conversions?

The FDA’s accelerated approval pathway has been attracting mounting criticism, but change is on the way. Bills seeking to reform the process have been introduced as part of this year’s reauthorisation of the biopharma user fee bill, while the agency’s new commissioner, Robert Califf, has made no secret of his desire to rectify weaknesses.

The latest stats on this area suggest that recent criticism as well as longer-standing admonitions have not fallen on deaf ears. More CDER accelerated approvals were converted to full approval last year than in any other, and a trend for faster conversions seems to be emerging.