Back in November 2021, the Lachman blog brought your attention to the changes coming with the new FDA reporting requirements that were instituted under the March 2020 CARES Act (section 3112(e)) when it was reported at the AAM GRx-Biosims conference. This new law, enacted for COVID‑19 response and relief, includes “enhanced” abilities for the FDA […]
FDA took action to fully approve Moderna’s Spikevax which had been the subject of an Emergency Use Authorization (EUA) since December 18, 2020. This means that the FDA has finalized its comprehensive review of the safety and efficacy of the Moderna vaccine. This is the second Covid-19 vaccine to gain full BLA approval status, the […]
Ozempic (semaglutide) is advertised on TV quite a bit. The jingle (identified in the title to this post) kind of sticks in your head. Ozempic is approved “for adults with type 2 diabetes used along with diet and exercise to improve blood sugar and lower A1C. It also lowers the risk of major cardiovascular (CV) events […]
Originally published on January 4, 2018, the Agency says it has finalized and revised the guidance document in response to “comments received on the draft guidance as the guidance was finalized and made minor edits and other editorial changes to improve clarity. Revisions include clarification of the recommendations pertaining to patent and exclusivity deficiencies, as […]
With ANDA reporting through January 21, 2022, the OGD has issued thirty full‑approval actions and eight tentative‑approval actions for a total of thirty‑eight approval actions issued so far this month. With only six more reporting days remaining, these unofficial numbers, gathered from the FDA All Approvals list here, it looks like the total approval actions […]
The Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance for the first quarter of FY 2022 (here) has both good news and bad news. The proverbial question is, which one do you want first? At this juncture, I might also point out that some of the data is also difficult to […]
We hit the number of December full‑approval actions on the head (thirty‑four) in our post here; however, we were way short on our estimate of tentative‑approval actions. We noted thirteen at the time of publication in the above‑listed article but the official total reported this morning was twenty‑two. Thus, the total number of approval actions […]
This morning, Sara W. Koblitz of Hyman, Phelps & McNamara posted a blog titled “Is The Skinny Label Back From the Dead?” (here) that suggests there may be hope for the skinny label after all. The blog details the GSK v. Teva decision and the potential dire implications for the skinny label. She also outlines […]
While it has been over a full month waiting for official approval numbers, receipts and complete response statistics for November of FY 2022 to post, and after bemoaning the delay in one of posts yesterday, they popped up either overnight or early this morning. The full approval actions hit 67 (we unofficially missed by one […]
According to Zachary Brennan of Endpoints News (see here), the FDA announced yesterday that it will hit the pause button again on upcoming routine domestic inspections due to the COVID-19 Omicron variant’s rapid spread. The initial pause will be for two weeks, but, depending on the state of knowledge about the status of the Omicron […]
