Well, September saw not only a low for this fiscal year (FY) of forty‑two total approval actions (both full (thirty‑nine) and tentative (three) approvals), but you have to go all the way back to February 2018 to find a lower number of total approval actions (thirty-seven). And, remember, that number was caused by the approval […]
On October 1, 2021, the FDA published the first list of monograph activities that will be prioritized to address areas of concern and the GRAS status of certain products under the new monograph system. The plan is currently to address these issues over the next few years; however, the Agency does not commit to assessing […]
Everyone knows that I am not a lawyer; I’m just a regulatory geek. But in the case of Catalyst Pharmaceuticals v. FDA and Jacobus in an orphan drug dispute, where the case rested on whether the phrase “same disease or condition” is ambiguous, there are few things that confuse me. The central issue is the […]
Today’s prepublication of the Federal Register (FR) contains the fees to be assessed for three priority review vouchers, namely the material threat medical countermeasure (MCM) priority review voucher; the rare pediatric disease priority review voucher, and the tropical disease priority review voucher. These fees were announced in three separate FR notices (here, here, and here). These vouchers are awarded to sponsors that submit and […]
There is a baking show on Netflix called “Nailed It.” The show is a riot, and its premise is based on amateur bakers trying to copy a creation baked by a famous pastry chef. The amateur baker that comes closest gets a trophy that says, “Nailed It,” even though (in reality) their end-product may look nothing like the professional’s version. Anyway, as far as the approval-action predictions we issued […]
The FDA has updated its first-generic approvals list for calendar year 2021 (here). The report is current through August 31, 2021 and lists a total of sixty-eight first-time approvals. As the FDA explains, “First generics are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product […]
On Monday, September 20, 2021, a guidance document entitled Questions and Answers on Quality Related Controlled Correspondence (here) hit the FDA webpage late in the afternoon. This document provides specific recommendations for generic drug quality issues that have been the raised repeatedly through controlled correspondence (CCs) submitted by numerous stakeholders. OGD decided to issue the […]
Through the last posting on the daily approval list on September 16, OGD has reported only 16 full approval actions and one tentative approval action. If this rate keeps up through the rest of the month, we are likely to see the fewest number of monthly approval actions since the beginning of the GDUFA program. […]
The FDA published its first arrears list for failure to pay FY 2021 Over-the-Counter Monograph User Fee Act (OMUFA) facility fees. Invoices were emailed on June 25, 2021 for fees not paid by the May 10, 2021 due date. And, holy smokes, there are almost 500 firms on the arrears list. Twenty‑eight are contract manufacturing organizations […]
Today, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here). This guidance responds to questions that have been asked by sponsors since the pandemic began, covers a multitude of issues, and outlines some areas of relief for applicants. Remember that the answers […]
