1. Pink Sheet

Shutdown Week Four: FDA Maintains Pre-Shutdown Output Pace In Some Cases

 
• By Derrick Gingery

ANDA and NDA/BLA supplement approvals continue thanks to carryover user fee funds, but US FDA hasn't made any NDA and BLA approvals during shutdown as as anxiety over effect of "lapse period" on agency increases.

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Anxiety about slowing FDA output increases as the partial government shutdown continues.

The US FDA has managed to maintain and sometimes exceed prior output levels during the weeks since the start of the partial government shutdown, although it appears that pace soon may diminish.

The agency has been using carryover user fee revenue to continue reviewing pending applications and perform other functions since congressional...

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