Click to view this webinar - Lessons Learned from a Review of FDA PRO Labeling
The last decade has seen an increased focus on patient-centered drug development. Product labeling based on patient-reported outcomes (PRO) endpoints are therefore of special interest to drug manufacturers. The Patient-Centered Outcomes Assessment team at RTI Health Solutions has analyzed FDA PRO labeling over the past ten years. The resulting study, A Review of Patient-Reported Outcome Labeling in the United States (2011-2015) is published in ISPOR's Value in Health. This webinar explores the trends in PRO-related product labeling and highlight some key observations found during the review.
Why listen in?
Knowing the trends and the lessons learned from this review of US product labeling will enable you to formulate better PRO labeling strategies. You’ll hear our experts in patient-centered outcomes and market access strategy have a conversation about their findings. They will cover what you need to know as you gather evidence about your product, and answer your questions about PRO labeling strategy.
You’ll learn:
- Trends in PRO labeling over the past 10 years
- Types of measures used for PRO labeling
- Diseases for which PRO labeling is likely
- Examples of successes and failures, and the lessons we've learned