This is a follow-up to the blog post “Houston, We Have a Problem” (here), noting that, with the exception of the one ANDA approval on September 5, 2023, no other ANDA approvals have been posted to either the Daily Approvals or All Approvals FDA websites through today!

As I mentioned in that blog post, this problem had occurred previously and it turned out to be a glitch in the FDA’s system. I contacted the FDA’s CDER press office and here is the reply I received:

“Thank you for your patience, it is much appreciated, and thank you again for your inquiry. There is a technical issue on our websites you referenced and are actively working on resolving the issue. We do not have a timeframe on when it will be fixed, but please check back often. We want to thank you for bringing it to our attention.”

While these things happen, it could not have come at a more inopportune time as we approach the end of FY 2023! Hopefully this will be resolved quickly and we will have a clear understanding of how the FY looks before too long.