There is no question that GDUFA III has brought with it a lot of changes. OGD has begun issuing Guidances and MaPPs to reflect the changes and updating those document that were issued under previous iteration of GDUFA. Rather than trying to paraphrase each Guidance and explain what changes have been made in the past […]
Just after we posted the blog about the other User Fee programs from the prepublication of the Federal Register, we receive an email from FDA indicating that the Fee Schedule was available, but there was a problem with the FR publication (here). Here are the new FY 2023 Generic Drug User Fees compared with the […]
With only the September metrics left to round out the FY 2022 statistical report for the OGD, let’s take a look at the full official numbers for August. We also now have a good idea how FY 2022 will stack up against FY 2021, albeit a lot can happen in a few weeks as we await the […]
Based on a strong start to the month, the OGD has issued forty approval actions but only two tentative approvals based on information posted through September 20th. Sorry that this mid‑month review was a bit late; with about two‑thirds of the month gone, I don’t expect to see another month like those we’ve seen lately. […]
With just two months to go in FY 2022, the OGD has updated its July statistical report (here). With the hold‑up on the FY 2023-2027 User Fee legislation, some at the Agency are getting a bit nervous about their job security and firms are scrambling to try to budget for FY 2023 user fee costs; […]
Well, we just passed the midway mark for August 2022 and it looks like a potentially good month for ANDA approval actions. Thus far (at least posted through August 16th), the OGD has issued thirty full-approval actions and eleven tentative-approval actions, well on its way to a high-70s or low-to-mid-80s number of approval actions. We […]
July looks like another good month for OGD approval actions with a reported sixty‑five full‑approval actions and thirteen tentative‑approval actions. In a previous blog post, we reported sixty‑five and twelve in our unofficial counts (here). That darn additional TA was posted after our blog post (so close!). So, the OGD hit over the seventy‑mark again […]
With a flurry of approvals at the end of the month, the unofficial count of approval actions for July 2022 breaks out as follows: 65 full approval actions and 12 tentative approval actions, for a total of 77 approval actions. This is the 7th out of 10 months that the total approval actions have broken […]
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) […]
