On August 8, 2023, Axios reported (here) that the Pentagon began contracting with Valisure, a drug testing facility, to test the generic drugs that it is purchasing. On August 9, 2023, Bloomberg reported much the same thing in an article titled “Tainted Medicine Fears Spur Pentagon to Seek Outside Testing” (here; subscription required). Congress has been pushing […]
The industry as a whole rejoiced on Friday with the publication of the new NDSRI guidance from the FDA, previously discussed here. Now that we all have had more time to carefully read and absorb the details posted by the FDA in the guidance and on the corresponding webpage, many will discover that there are […]
According to currently published figures as of July 6, 2023, OGD has issued 68 full approval actions and 15 tentative approval actions for a total 83 total approval actions for the month. The 68 full approval actions represent the third highest number per month for the 10 months of FY 2023 and the 83 total […]
Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products. As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]
The statistical report (here) provides full official statistics through the third quarter Fiscal Year (FY) 2023. There is some good news when looking at mean and median approval time that we will discuss later. But for now, let’s look at some of the more important FDA approval actions for June 2023. OGD approved 76 new […]
With summer in full swing and many people on vacation or thinking about their upcoming vacation, I decided to look forward to the fall and an upcoming GDUFA commitment on Suitability Petitions (SP) that begins on October 1, 2023. But first, let’s look back on events related to SPs in Calendar Year (CY) 2023. Earlier this year, […]
On the Federal Register (FR) prepublication page today, the FDA outlined the new fee schedule for generic drugs under the GDUFA program for FY 2024. Make sure you have a bottle of Maalox nearby before you read the rest of this blog as the increases, especially for the program fees, might cause you some agita. Generic […]
Back on January 30, 2023, I wrote a blog (here) concerning a petition that was filed by Vanda Pharmaceuticals regarding a perceived difference in labeling between the brand and generic drug. In this case (and please see original post to familiarize yourself with the details), the firm claimed that the generic excluded braille from its […]
With the latest news that a tornado severely damaged a Pfizer sterile injectable plant in North Carolina, it is clear that Mother Nature is yet another interloper into the drug shortage problem in the United States. Ed Silverman, of the publication STAT, reports that “Among the damaged buildings was a Pfizer plant in Rocky Mount, […]
After a slow start to the month, the steam is beginning to power up and halfway through July, OGD has issued 32 full approval and 9 tentative approval actions, so it looks like it should wind up being a good month if the last week’s proliferation of approvals continues. These figures represent postings of Approval […]
