There is a hint that the “pause” or freeze on communications from the FDA may be starting to thaw. This morning, a CDER Small Business and Industry Assistance (SBIA) Webinar titled Navigating Controlled Correspondences to Support Generic Drug Development, to be held on February 27, 2025 from 1:00 to 3:30 p.m., was posted with a request for registration. This is the first webinar that I’ve seen posted since the “pause” took effect, and it’s being presented in just two days. The time frame for such postings is usually weeks in advance!
Other postings on the What’s New page at CDER continue to languish or contain only safety announcements or significant approvals. For instance, there have been no What’s New items published since February 14, 2025. We usually see various publications on that page almost daily.
When will the pause end? What changes will we see in the previous transparency that we all fought for and have seen with the FDA? What will the new normal be? Unfortunately, only time will tell!
