M. Nielsen Hobbs
Latest From M. Nielsen Hobbs
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.
America still has a long way to go to meaningfully contribute to ending the global pandemic, but loaning AstraZeneca’s vaccine to Canada and Mexico helps counter the narrative that only China and Russia are helping the rest of the world.
Conveniently omitting Germany’s BioNTech, the US president says ‘development, manufacture, and distribution of the vaccines in record time is a true miracle of science. It is one of the most extraordinary achievements any country has ever accomplished.’
Our infographic offers a composite sketch from a decade of US FDA data on refuse-to-file letters.
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.