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 […]
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was submitted asking the FDA to make a determination that certain Alcohol and Dextrose injection products were not withdrawn for safety or efficacy (S&E) reasons; In a Federal Register notice (here), the Agency took the opposing view and stated that all Alcohol and Dextrose injection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 […]
