In its “FDA Roundup: February 4, 2022,” the FDA announced that “on Feb. 2, the FDA determined that beginning on Feb. 7, the agency will resume conducting domestic surveillance inspections across all commodities given the decline in COVID-19 cases across the country.” The FDA says that it will continue to conduct mission‑critical foreign and domestic […]
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 […]
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4, 2018, the Agency says it has finalized and revised the guidance document in response to “comments received on the draft guidance as the guidance was finalized and made minor edits and other editorial changes to improve clarity.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 […]
