FDA’s tally of novel approvals in 2011 is impressive, as early trends predicted, but the agency’s consistently strong performance on a range of review metrics shows that improvements in review performance ran deep.
The agency has been trumpeting the 30 new molecular entity and new biologic entity approvals from CDER in 2011 – the most since 2004 and a welcome sign of recovery after the approvals doldrums in between – but it also deserves recognition for achieving an unprecedented, near-perfect rate of PDUFA review goal compliance (96.7%) while maintaining healthy rates of first-cycle approvals (63