Join Frances Zipp, President and CEO of Lachman Consultant Services, Inc., at the AAM Annual Conference, Access! 2022, where she will moderate the WiHP Healthcare Leadership luncheon. The panel discussion will be held on February 15, 2022, at 12:30 pm. Frances will be joined by AMCP CEO Susan Cantrell, AHIP’s EVP of Government Affairs and […]
Join Frances Zipp, President and CEO of Lachman Consultant Services, Inc., at the AAM Annual Conference, Access! 2022, where she will moderate the WiHP Healthcare Leadership luncheon. The panel discussion will be held on February 15, 2022, at 12:30 pm. Frances will be joined by AMCP CEO Susan Cantrell, AHIP’s EVP of Government Affairs and […]
On February 2, 2022, I posted a blog on the Agency’s Guidance Agenda for 2022 (here) and chose seventeen of the ninety‑eight guidances listed that were my favorites for a number of reasons, but most of all due to what I felt was their significance. And, today, one of the guidances I had selected was […]
Sanitation Tunnels, as the name implies, are tunnels where a spray mist of antiseptic or disinfectant can be sprayed onto humans or animals. These tunnels, according to the FDA, were first employed in China and are being used in countries outside the United States to treat or prevent the spread of COVID‑19. The FDA further […]
January 2022 was a much better month than the previous, thanks to (what looked like) an end‑of‑the‑month approval flurry as twenty‑seven ANDAs received full‑approval actions in the last five business days. Remember that these are unofficial totals gathered from the FDA’s Recent New and Generic Drug Approvals list (here) and the Agency’s All Approvals List […]
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 […]
