There are a few items I’ve seen that give me hope that the communications ban may be coming to an end soon. However, there are still some mysteries in the ban that confuse me. For instance, there have been no approvals listed on the CDER webpage (here) since January 22, 2025. But today, for the first time since the ban was announced, two Federal Register notices appeared on the FR pre-publication page, both related to “Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Requests,” the first for “Labeling Requirements for Prescription Drugs” (here), and the second titled “Biosimilars User Fee Program” (here).
The ban excludes safety announcements and those have continued to be published. I haven’t noticed any additional continuation of previously daily-published information.
One thing that I did notice is that the agenda for the Association for Accessible Medicines (AAM) has been updated to remove any of the previously invited FDA participants, who, because of the temporary ban (which includes speaking engagements), have been replaced by other top healthcare professionals and industry leaders. I will be there to hear their excellent presentations and listen to their views. If you are also planning to attend, please stop by to see me, Fran Zipp, Marty Shimer, and others at Lachman’s booth at the meeting, which is taking place February 3-5, 2025 in Amelia Island, Florida. Registration can be found here.