The FDA recently released a Draft Guidance on developing new treatments for acute migraine. Of note to those involved in patient-reported outcomes are the sections on endpoint selection which suggests that sponsors examine multiple domains (other than pain itself) as well as the most bothersome symptom to the patient (i.e. nausea). Find the guidance here
The FDA has recently posted a Draft Guidance on the procedure for requesting and presenting at a meeting with the Center for Drug Evaluation and Research (CDER). One of the potential topics pharmaceutical companies may want to address at a meeting with CDER concerns development of clinical outcome assessments in the early parts of clinical development prior to a new COA being ready for formal qualification. Vector Psychometric Group has experience presenting the benefits of modern psychometric techniques to the FDA.