US FDA’s New Drug Median Review Time Held Steady At Eight Months In 2021
The median review time for novel agents at CDER hasn’t changed in five years. Our infographic offers a look at the tortoises and hares (all of them winners because they got approved).
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The sprawling safety surveillance system is propelling advances in informatics and advanced analytics, but the agency is delaying next contracting cycle to digest its experience.
AstraZeneca’s Truqap and Evive’s Ryzneuta bring FDA center for drugs’ 2023 novel agent total to 51, while biologics center already sits on a record-breaking 14 novel approvals.