Pink Sheet reporters and editor discuss the issues surrounding an FDA warning letter on Dsuvia promotion, an expected jump in CDER coronavirus-related workload, and a study of refuse-to-file actions.

Pink Sheet reporters and editor discuss the latest coronavirus vaccine news, CMS’ effect on the future of aducanumab, as well as new assessment goals for PDUFA VII.

Pink Sheet reporters and editor discuss Biden’s look at coronavirus dose-sparing strategies, FDA plans for vaccine adjustments in lieu of viral variants, new CMS administrator candidates and groups lobbying for the new FDA commissioner.

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

The US missed even its revised year-end target for COVID vaccines, but the news isn’t all bad; there’s steady progress on clinical research even as federal officials seem out of ideas for how to speed actual vaccinations.

States had received less than they expected, and Operation Warp Speed and Pfizer had taken swipes at each other, but that all seems smoothed over now – even though it’s still not exactly clear how much of Pfizer’s COVID vaccine will be available to the US by the end of year.