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 There were twenty ANDAs withdrawn in November (two were approved ANDAs that were likely no longer marketed) and eighteen […]
The World Health Organization (WHO) issued a draft guidance document titled “Guideline on Data Integrity” (October 2019) and within the document there is the statement: “Quality risk management (QRM), control strategies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 […]
Training Fundamentals: Important to Baseball and the Analytical Laboratory By Tim Rhines, Ph.D | December 6, 2019 | Compliance, FDA, Laboratories, Science & Technology | 3 | Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training. At this time, team management is evaluating where the team succeeded and where improvement is needed. It […]
Reading Derrick Gingery’s article “ANDA Approval Records Will End As U.S. FDA Mops Up Backlog” (here) in today’s Pink Sheet about Dr. Woodcock’s contention that the clearance or “mop up” of the backlog will impact the number of generic drug approvals, I was somewhat stopped in my tracks. Granted, the backlog of old applications did […]
Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect. A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”. Since the beginning of time, the Agency […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
