FDA Solidifies 2014 As Breakthrough Year With December Drug Approval Rush
FDA hit high notes with new drug and therapeutic biologic approvals in 2014, turning in an 18-year high total of 41 novel agents – more than 20% with “breakthrough” therapy status – but the agency’s continuing consistency in review performance is the underlying theme.
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In addition to a spate of FDA approvals closing out the year, Roche contended with trial failures and Actavis received a “complete response” letter for its nebivolol/valsartan combination.
Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.
Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.