While I do happen to reside in California, I won’t take any blame for the Governor’s idea for California to become a private-label distributor of generic drugs. This idea leaves me scratching my head and may have something to do with someone smoking some really potent wacky weed. Sorry that I don’t know the specific […]
OGD reported the approval of 108 first time generic approvals in CY 2019. This is the highest total in at least 4 years, with previous totals of 99 for 2018, 80 for 2017, and 73 for 2016. There are many reasons for variations in the number of first approvals, some of which relate to the […]
In the Federal Register pre-publication notices today, the FDA announced an opportunity for hearing for 249 ANDAs that it proposes to withdraw because the applicants have repeatedly failed to submit Annual Reports. The notice announces the opportunity for a hearing for any of the applicants. Many of the ANDAs are old applications, with some from […]
Today is January 8th and the OGD just updated the November 2019 metrics (here) with the following information of interest: the OGD refused-to-receive three ANDAs (all of which were standard applications) and acknowledged fifty-five original ANDAs. There were twenty ANDAs withdrawn in November (two were approved ANDAs that were likely no longer marketed) and eighteen […]
The World Health Organization (WHO) issued a draft guidance document titled “Guideline on Data Integrity” (October 2019) and within the document there is the statement: “Quality risk management (QRM), control strategies and sound scientific principles are required to mitigate such (Data Integrity) risks” and then further it states: “application of QRM with identification of all […]
I am saddened to report that on Saturday January 4, 2020 my (our) good friend Don Hare passed away peacefully after a brief illness. When I heard the news, my heart broke. For those of us in the FDA or in the drug industry, he stood as a man among men and will be sorely […]
The Agency issued two warnings today, one about a recall due to a drug-strength labeling error for Mirtazapine and the other regarding a potential serious adverse event, breathing difficulties, associated with the use of gabapentinoids. It appears that there was a label mix-up with a single lot of Mirtazapine and “Aurobindo Pharma USA, Inc. is […]
With the first quarter of FY 2020 in the rearview mirror, a review of the FDA’s All Approvals list (here) and the FDA’s Recent New and Generic Approvals list (here) looks like the new monthly normal for full approval actions will likely be close to sixty per month with about an additional ten tentative approval […]
