The Center for Devices and Radiological Health's next Office of Device Evaluation Director will possess a medical degree, CDRH Director David Feigal said in a Nov. 9 interview with "The Gray Sheet."

US FDA considering approach that is similar to, but more stringent than, influenza strain changes, CBER Director Marks says. But how to know what variants need a limited study and which one need a big one will be an ongoing challenge, NIH's Graham notes. As FDA and sponsors gain more experience with tweaking the vaccines to account for new coronavirus variants and strains, the process may be expedited further.