1. Pink Sheet

NDA/BLA Approval Totals: Will US FDA Recover From Slow Start Again?

 
• By Derrick Gingery

Since 2018, the agency usually has increased its average NDA/BLA approvals per month after April, but the data also suggest an overall downward trend in productivity.

slowdown
Average NDA/BLA approvals per month is lower than years past through the first third of calendar year 2023. • Source: Shutterstock

The first four months of 2023 may not necessarily predict the future, but suggest stakeholders should watch for a potential approval slowdown at the US Food and Drug Administration.

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