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 […]
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 […]
In today’s Federal Register (here), the FDA announced the availability of a final guidance for chemistry manufacturing and control changes (CMC) that may be reported in an annual report (AR). CMC changes that may be submitted in an annual report are considered minor changes. The FDA says, “This final guidance updates the draft guidance of […]
Here we are, another Thanksgiving almost in the books, and reading the newspaper or listening to the news makes one wonder what we have to be thankful for. Then an old Bing Crosby song comes to mind… “You’ve got to ac-cent-u-ate the positive, e-lim-in-ate the negative. Latch on to the affirmative. Don’t mess with Mister […]
Well, a day more than halfway through November and the approval pace, at least for full approvals, has been brisk. Through those approvals and tentative approval actions posted through November 16th on the FDA All Approvals list (here) there have been 38 full approval actions and only 1 tentative approval actions. November has at least […]
On Friday afternoon, the OGD posted the remainder of the metrics for the last month of FY 2021. While we know what the approval statistics were for the full year, along with the comparisons for previous FYs since the inception of GDUFA (see previous blog post here), there are other interesting metrics that need to […]
Well, the first month of FY 2022 appears to be an improvement over the last month of FY 2021, which was reported as forty-nine total approval actions, as the OGD hit an unofficial total of sixty-two in October 2021. The total is broken down into fifty full-approval actions and twelve tentative-approval actions. Usually, a few additional […]
