With just three months left in FY 2022, the OGD provided its update, adding the rest of the June statistics. We now have a full picture of the first three quarters of the metrics provided in the FDA Generic Drugs Program Activities Report – Monthly Performance. Here are some highlights of the complete June report […]
For each FY quarter, the OGD publishes a series of metrics (as agreed to in the GDUFA II commitment letter) that identify the FDA’s workload by indicating the number of ANDAs awaiting the OGD’s action, including new ANDAs submitted each month, with separate line‑items for tentatively approved (TAed) ANDAs awaiting approval (the FDA’s current ANDA workload) […]
July had some fireworks early in the month, and when the smoke cleared on July 15th, the OGD reported twenty‑nine full‑approval actions and seven tentative‑approval actions (thirty‑six in total). If this pace continues, the OGD should surpass seventy total approval actions again this month. For the nine months already officially in the books, six of […]
In an earlier post (here), we projected the June approval number to be 52 full approval actions and 19 tentative approval actions. This morning the FDA published its official approval actions as well as other metrics (here) and our projections were spot on. The total of 71 approval actions (52 + 19) were exactly what […]
On July 1, OGD updated its monthly statistical report for May 2022 (here). The additional stats (while not particularly remarkable) outline the workload output for the ANDA review and approval process and should be of interest to most of us that pay attention to OGD output. Highlights of the final May statistical report appear below. […]
Well, just like that, OGD posted the official approval actions along with some other metrics for May and also updated the rest of the April statistics. We have been touting the May approval action and we were ever-so-close but missed by one. The actual official May approval actions are as follows: Full approval actions 84 […]
June looks fairly strong but likely not as strong as May’s projected unofficial total (ninety‑three full and tentative actions). With postings through June 14th on the FDA’s Daily and All Approval lists (here and here), as of 10:30 a.m. on June 16, 2022, there were twenty‑three full‑approval actions and nine tentative‑approval actions. This total of […]
The March statistical update to the Generic Drugs Program Activities Report – Monthly Performance brings the refuse-to-receive (RTR) count back to a manageable number of three, which has been seen every month so far this FY except for last month, which saw triple that number. The OGD also acknowledged sixty‑two ANDAs in March. Other metrics […]
If we say so ourselves, we totally nailed the full-approval actions for March when we reported the unofficial number at sixty-three (see previous post here) but, at the same time, we missed big time on the tentative-approval actions, which we reported at four – well, the official TA approval actions were just reported at eighteen! […]
According to the Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance published yesterday, the Office of Generic Drugs is looking at over 1,712 ANDAs that are pending Agency action. While down a bit from the 1,749 reported at the end of the first quarter, the number jumped from the end of […]
