CALL US +44 (0)1462 440 084 | +1 919-882-2016 | Contact | Submit RFI

Patient Reported Outcomes (PRO) to Support Medical Product Labeling Claims

Statistical Consultancy Team

With encouragement from the U.S. Food and Drug Administration (FDA), using Patient Reported Outcomes (PRO) data to claim labeling became more and more popular. Well-defined and reliable PRO can be used to support a claim in medical product labeling. [1] It is found that there are an increasing number of regulatory submissions for new drugs to provide PRO data to support claims. DeMuro et al. (2013) [2] have reviewed drug approvals by both FDA and EMA for the years 2006–2010. They found that out of 75 drugs approved by the EMA, 35 (47%) had at least one PRO related claim approved by the EMA compared to 14 (19%) for the FDA.

Read More
Topics: FDA, European Medicines Agency, Biostatistics Consulting, Patient Reported Outcomes, medical labeling, PRO Instrument, Electronica Patient Reported Outcome (ePRO), Statistical Analysis Plan

Welcome to The Quanticate Blog

We aim to provide information and support written by our experienced staff. We want to share our knowledge and create an archive of information that you will be able to engage with, share and comment on.

Subscribe to Email Updates

Blog Suggestions

Most Read

Posts by Topic

Expand all