New Drugs Show How FDA Incentives Look Beyond Innovation
FDA’s first-in-class drug approvals show a healthy rate of innovation, but the 2014 novel agent cohort is more notable for the high level of clinically meaningful advances in therapy for serious diseases. Two-thirds of CDER’s novel approvals qualified for at least one expedited development and review program; only half of those products represent a new pharmacologic class.
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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.
Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker