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 […]
December of FY 2021 sure didn’t break any records as the OGD managed to eke out only 34 full‑approval actions and 13 tentative‑approval actions. We would have to go all the way back to February 2018 to find a lower full‑approvals total for a month, and the total for that month was 32. The tentative‑approval […]
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 […]
The FDA’s Center for Devices and Radiological Health issued two guidance documents to address the transition plans for device EUAs issued during the COVID-19 public health emergency (PHE). The first guidance is titled Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and the companion […]
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was submitted asking the FDA to make a determination that certain Alcohol and Dextrose injection products were not withdrawn for safety or efficacy (S&E) reasons; In a Federal Register notice (here), the Agency took the opposing view and stated that all Alcohol and Dextrose injection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 […]
FDA approval actions listed through December 15th include only seventeen full‑approval actions and six tentative‑approval actions for a total of twenty‑three total approval actions. As it stands, if these numbers represent one half of a month, it would mean that, at the current pace, we would see forty‑six total approval actions for the month of […]
Today, the FDA published an update to the list of non-patented drug products and products that are protected by exclusivity provisions. The new twist in the current version of the list is that it is in two parts. One part covers prescription drug products and the other covers OTC products that are FDA-approved. The list […]
Confused About the Global Requirements for Nitrosamines? We will Help You Navigate This Unchartered Territory! Nitrosamines are a well characterized family of carcinogens that has been identified in thousands of consumer products recently, including small molecule pharmaceuticals and other finished goods. They are produced by the chemical reactions of a nitrosating agent with structural elements […]
