FDA’s Pediatric Data-Extrapolation Policies Questioned At Asthma Panel
Should using adult data to label a product for kids be ‘a judgment call?’ Advisory committee asks whether FDA needs more explicit criteria during review of GSK’s Breo Ellipta.
Should using adult data to label a product for kids be ‘a judgment call?’ Advisory committee asks whether FDA needs more explicit criteria during review of GSK’s Breo Ellipta.