US FDA Guidance

Excerpt

For centuries past, the appearance of a new stellar object has been regarded as the harbinger of doom, Halley’s Comet being but one example of a worldwide phenomenon with a socio-political impact that is recorded across history. The arrival of US FDA guidance on ‘patient-reported outcomes’ has been anticipated for some time past, not least by those in outcomes research, academia and industry who participated in the preliminary close encounters that provided the motive power which fuelled its evolution. This background is important in locating the present guidance document since it provides an insight into unresolved issues. …