Here we are in February 2022 and the FDA has updated the full report of statistical metrics for December 2021. Let’s take a look at some metrics of interest. We are three for three – for refuse‑to‑file (RTR) actions, that is. Each month in FY 2022, we have seen the OGD issue three RTR actions. […]
On January 31, 2022, CDER released its Guidance Agenda for new and revised guidances expected to publish in 2022. While the list is somewhat aspirational, it provides a window into what the Center is working on and what we might see this year. The document lists 98 new and revised guidance and can be found […]
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 […]
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 […]
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 […]
The Center for Drug Evaluation and Research (CDER) approved 50 novel therapies in 2021 which are described in a recently released 26-page report (here) that discusses in some detail the 50 novel products and their bearing on treatment for patients. The report discusses the mechanistic pathway for approval and provides a list of all the […]
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 […]
The IPledge Risk Evaluation and Mitigation (REMS) program was designed to address the significant potential for serious birth defects should a pregnancy occur during treatment with the drug isotretinoin which is used to treat acne. The program covers both males and females, since isotretinoin can be passed through the semen of males if the male […]
