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 […]
The OGD updated its statistics for the first month of the fiscal year but here we are on December 23 and the usual November early stats for approvals, Complete Response Letters, and new ANDA submissions have not yet posted. Anyway, back to the October updated statistics. There were 3 refuse-to-file (RTR) letters issued to start […]
In a move not often seen, a Citizen Petition was submitted asking the FDA to make a determination that certain Alcohol and Dextrose injection products were not withdrawn for safety or efficacy (S&E) reasons; In a Federal Register notice (here), the Agency took the opposing view and stated that all Alcohol and Dextrose injection products […]
COVID came, and it’s frightening Can strike you down, just like lightning We will like it a lot if you get your shot Living in COVID blunder-land This has been a year of tension With too many bloody problems to mention Hopefully in not long, COVID’ll be gone Living in a COVID blunder-land […]
Yesterday, the FDA published a document (here) detailing potential impact on the performance of specific COVID-19 detection tests for the Omicron variant as well as other variants of SARS-CoV-2. The FDA listed tests that may have reduced ability to detect the SARS-CoV-2 Omicron variant and provided a list of thirty‑three sites at which this test […]
FDA and industry have long wrestled with appropriate dissolution methodology for injectable suspension products. Investigations into the relevance of the dissolution methods utilized has shown wide variation in in vivo results despite consistent in vitro performance. As FDA notes in a recent article (here) on the new potential improved method developed to address “gaps between […]
Well, OGD is back over the 70 mark for total number of approval actions in a single month, with what appear to be at least 72-66 full approval actions and six (6) tentative approval actions reported, going by the numbers posted at 11 AM EST December 3 on FDA’s website. The last time OGD had […]
FDA has released its revised outline of specific generic drug research priorities for FY 2022 (see here) based on feedback of stakeholders in a public meeting held on June 23, 2021 as well as written comments received on the 15 proposed research priorities announced at that meeting and the issues that FDA sought comments on […]
In a news release on November 15th (here), the FDA announced that ”the U.S. Department of Health and Human Services withdrew a policy that directed FDA not to enforce premarket review requirements for laboratory developed tests (LDTs). This action will help ensure that COVID-19 tests are accurate and reliable.” The Trump policy was a misguided […]
