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 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was submitted asking the FDA to make a determination that certain Alcohol and Dextrose injection products were not withdrawn for safety or efficacy (S&E) reasons; In a Federal Register notice (here), the Agency took the opposing view and stated that all Alcohol and Dextrose injection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 […]
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 […]
On December 10, 2021, the FDA issued a guidance titled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions, which can be found here. The guidance suggests that ANDA applicants can help their own causes by utilizing a checklist as an attachment to the cover letters of ANDA submissions and controlled correspondences submitted to the […]
Today, the FDA published the eighth revision of a guidance titled Part VI: Impurities: Residual Solvents (Maintenance): PDES For 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tertiary-Butyl Alcohol (here). This revision adds the three residual solvents named above and provides permitted safe daily exposure (PDE) limits for patients. The guidance provides information on the solvents themselves, the […]
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 […]
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 […]
