Trends in EMA and FDA Labeling

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Webinar: Characteristics of Recent PRO Labeling by the FDA and EMA for Oncology Drugs

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Trends in EMA and FDA Labeling Based on Patient-Reported Outcomes (PROs)

A recent review of labels from drugs approved by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for cancer treatment found that the agencies use different standards to evaluate evidence from patient-reported outcomes (PROs) in clinical trials. Study sponsors pursuing PRO drug labeling who understand these differences can use that knowledge to guide their PRO measurement strategy. 

This webinar, hosted by study authors and based on PRO labeling of cancer treatment drugs, focuses on key differences between the 2 regulatory agencies. Popular myths will be debunked, oncology studies inefficiencies will be exposed, and emerging trends will be highlighted to help sponsors pursuing labeling claims from both agencies.

Learning objectives

• What are the main characteristics of the labels granted by the FDA and the EMA for PRO-related endpoints, including feedback on specific outcome measures?

• What are the main challenges sponsors face when including PRO-related endpoints in cancer clinical research? And how can these challenges be overcome?

• What are the emerging oncology labeling trends in the regulatory environment?