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Re: Talon38 post# 453054

Friday, 03/01/2024 1:51:18 AM

Friday, March 01, 2024 1:51:18 AM

Post# of 462040
Talon, thanks for bringing that to the board. I'm about 1/3 through the list of FDA decisions. This certainly give a good view of the volume of work the FDA does as well as the number of applications that result in a Complete Response Letter. It is surprising how many CRLs are for manufacturing inspection failures.

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