Pink Sheet reporters and editor discuss the influence of the emergency use authorization on FDA decisions, another twist in the march-in rights debate, and how CBER is not using the real-time oncology review program.

Pink Sheet reporters and editors consider the impact of pre-announced domestic inspections, as well as look at the various COVID-19 vaccine safety monitoring programs and new data on application decisions during the pandemic.

Pink Sheet reporters and editors discuss the impact of the COVID-19 pandemic on pharma and the FDA and consider former commissioners’ pleas for President Biden to nominate a permanent agency commissioner.

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.

Pink Sheet reporters and editors consider the implications of a Democratic Congress for the pharma industry, ongoing problems with slow coronavirus vaccination rates, and the high CDER novel approval count in 2020.