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 […]
Today in a prepublication Federal Register notice, (due to be published tomorrow), the FDA announced the addition of 29 new and 19 revised product specific guidance (PSG) documents. The Agency acknowledges that, “as part of FDA’s commitments under the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), FDA will publish guidances for reference […]
Depending on the context, a year can either seem like an eternity or a rather short period of time; the details and context will always matter. In the draft Guidance for Industry issued on July 22nd (here ), the Office of Generic Drugs (OGD) laid out its expectations for complying with the regulatory requirement for […]
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 […]
When we did our peek at the June Approval numbers mid-month (here), we predicted that June would be a good month and, at the time, indicated that there would likely be approval actions somewhere in the mid-60s. Well, OGD put the push on, and they actually broke the 70 barrier with 71 total approval actions […]
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 […]
The FDA has updated its list of all ANDA final approvals for drug products that have received CGT designation. The list cites a total of 150 ANDAs and the first approval under the program dates back to August 8, 2018. So far in 2022, FDA has approved 29 such ANDAs, of which 10 have commenced […]
The “rain” of approval actions in April led to an unofficial “sprouting” of 83 full approvals in May, which was the largest number of full approvals seen in quite some time; specifically, since May 2019 when there were also 83 full approvals. While not an all-time high for a single month, it is a welcome […]
There has been legislation introduced recently to change the provisions as to how the 180‑day award for being a first filer in a paragraph IV patent challenge works. The FDA has proposed some alternate changes as well, outlined in a current blog by our friend Kurt Karst (here). If you want your head to spin […]
