What are the PROLabels inclusion criteria?
From the FDA website, the last available drug label is reviewed to search for PRO claims in the Clinical studies section. In case of doubt, the corresponding Medical Review is referred to make sure that the measure involved a PRO (when available). From the EMA website, we review all Summary of Product Characteristics (SPC) to search PRO efficacy endpoints in the 5.1. Pharmacology section, and gather additional information from the Scientific Discussion when necessary.
