US FDA explains how to use patient-reported outcomes to support labelling claims
This article was originally published in SRA
The US Food and Drug Administration has issued final guidance explaining how it evaluates patient-reported outcomes to measure treatment benefit in medical product clinical trials1,2.
You may also be interested in...
The European Medicines Agency is developing a strategy to ensure that women have sufficient information to make informed choices about taking medicines during pregnancy and breastfeeding.
A first-of-its-kind collaborative study has found that real-world and natural history data are comparable to placebo data from clinical trials in Duchenne muscular dystrophy.
An EU group has listed several ambitious projects to help EU regulators realize their cherished vision of using big data capabilities to support innovation and public health. But these proposals may take a backseat as COVID-19-related challenges continue.