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ood morning, everyone, and welcome to the middle of the week. Congratulations on making it this far and remember there are only a couple more days until the weekend arrives. So keep plugging away. We, in fact, are endeavoring to do just that as we near the end of a fruitful road trip. Once again, this means our posting will be limited, but the void will be filled by a few trusty colleagues. Meanwhile, please enjoy a few tidbits. Hope your day is a success …

The Food and Drug Administration in October issued 325 complete response letters to 325 abbreviated new drug applications and approved or tentatively approved 101 applications, Regulatory Focus observes. These are the highest numbers in a single month since the enactment of Generic Drug User Fee Amendments.

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