After a few inquiries about the lack of public approval action reporting for ANDAs at the end of August and thus far through September 25th, it appears that our reporting revealed some type of a problem. Although we do not know the exact nature of the problem as of yet, we received a nice note from the FDA press office. “Thank you for bringing to our attention the approval discrepancy. The Office of Generic Drugs reached out to the appropriate Center for Drug Evaluation and Research staff to improve the posting process”, they wrote.
Interestingly enough, there was a problem over a year and a half ago, but that was fixed, and the public reporting on both the FDA Daily Approval List and the FDA All Approvals list were pretty accurate. Just recently, however, is when the problem reared its ugly head again (and in a big way), as explained in recent posts (here and here). Just to emphasize the importance of the transparency of these numbers, and the head scratching when they don’t appear, there were no full approvals posted on either of the two sites above for August 28, 29 and 30, and September 3, 6, 11, 12, 16, 17,18, 19, 20, 23 and 24. We knew that was not correct, and my guess is that industry was getting a bit antsy about the apparent lack of approval actions.
You know how it is when your computer, that has always done something correctly, then decides it just does not like doing it that way anymore! Well, we are glad to see that the message was delivered and that soon again we can look to be back on track – tracking one of the most important metrics that OGD has to deliver!
