Given all that’s happened with the federal government this past week, it’s no wonder that we’re not hearing much from the OGD. Communications appear to be quite slow to appear. Even the Federal Register prepublication page has few FDA postings over the last three weeks. Another instance of communication lapse: since March 7, 2025, only safety notices and statutorily mandated information (e.g., certain reports) and Orange Book updates have been posted on the FDA’s website; there used to be a flurry of other types of information found on the What’s New page, but that flurry appears to have subsided.
We’ve seen no new ANDA approvals since one was posted on March 17, which would be very unusual, especially at the rate of approvals coming out of the OGD since October 1. There have been a few New Drug Applications posted. My guess is that the person in charge of assuring that ANDA approvals post is either overwhelmed with other work or is no longer employed by the FDA. It may be possible that the OGD will only be reporting approval information when it report its actions monthly, albeit about two months behind the close of each month. I thought that the reporting of supplemental approvals for both ANDAs, NDAs, as well as BLAs was an automated function, dictated by the issuance of the approval letters for the applications. I assume that there is another clearance step prior to publishing the information that may be delaying postings.
There is an FDA Webinar scheduled for April 9-10 that appears to be going forward as there has been no indication of cancelation of the event.
But, for now, many of us in the industry are wondering whether the communication patterns that we’ve become used to seeing will restart once the dust settles or whether we can expect that we’ll no longer see certain reporting or reporting of other communications that we’ve become accustomed to. Since transparency from the FDA has improved dramatically over the past few years, I hope this step back will be temporary.
