Latest From Kate Rawson
The move means Hylton Joffe can focus exclusively on his role as director of the Office of Rare Diseases.
The agency historically has had challenges recruiting experts for its advisory committees. With most everyone working from home during COVID-19, that task was just made easier, 3D Communications’ Jim DiBiasi says.
While a vaccine candidate is still months away, US FDA is already working to identify manufacturing capacity, CBER’s Peter Marks says in an interview.
The best vaccine development program would include robust clinical trials, CBER Director Marks says in an interview, but that depends on what’s happening with viral transmission on the ground.
Just as COVID-19 work begins to wane, CBER’s Peter Marks expects an influx of gene therapy work as sponsors attempt to salvage clinical trials.
Office of New Drugs Director Peter Stein outlines how his reviewers are prioritizing COVID-19 work, and how he is reallocating resources to the pandemic response.