Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]
In my October 5, 2021 post (here), I discussed what appeared to be a significant dip in ANDA approval and tentative approval actions, as well as a decrease in the number of ANDA submissions. I mentioned that I did not have further insight as to the decline in these metrics but did mention that maybe […]
According to the FDA All Approval list, OGD reported 28 full approval actions and two (2) tentative approval actions thru 10AM ET on October 15, 2021 (here) for a total of 30 approval actions midway through the month. This is a more favorable figure than we reported for the midway point of September (here) where […]
Well, we have been seeing certain information on ANDA suitability petitions since FDARA passed, but only the information required by the Act. The FDA reports a separate list of petitions that have been filed, those that are pending, or those that have been acted upon. Unfortunately, according to the FDA page where the list resides […]
Overnight, FDA updated its metrics for August and also provided some critical metrics to end out FY 2021 (here). Let’s take a look at the August update first. OGD issued three (3) Refuse-to-Receive letters in August, which appears to be consistent with the numbers for the year (with the exception of 11 RTRs that were […]
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 […]
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. […]
It’s another month of full stats in the books, but not much to cheer about. Let’s have a look at some of the highlights (or lowlights, if you will) of the month’s statistics. OGD Refused-to-Receive (RTR) 4 ANDAs in July and all four were for standard ANDAs. The average RTRs per month through the first […]
The Competitive Generic Therapy (CGT) program, which began in 2017 as a means to bring generics for products that had inadequate competition to market faster, has hit (and actually surpassed) the century mark in terms of the number of approvals. As the FDA notes in its announcement today, the authority for the program comes from […]
