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Evaluation ViewAttendees 17

Pharmaceuticals (includes Biologics & Drugs)

Is it Time for a New Patient Experience Data Section in Product Labeling?

Thursday, October 9, 2025
3:15 PM - 4:15 PM EST
Location/Room: 304
As Patient Experience Data (PED) continues to be included in product development and regulatory submissions, the need for that data to be reflected in the label becomes of increasing importance. However, while PED is often included in drug development and considered by regulators, it often fails to make it into product labeling. One way to address this challenge would be to create a new section in the product label specifically intended for Patient Experience Data. This new section would provide valuable insights into how medications affect patients' daily lives, beyond just clinical efficacy and safety data.

This panel would include industry and regulatory panelists and discuss:
• Benefits of having a section dedicated to patient experience in labeling;
• What would be required to create this new section in labeling; and
• Potential challenges of a new PED labeling section.

The potential benefits of including patient experience data in labeling are substantial. It could lead to more personalized treatment approaches, improved shared decision-making between patients and healthcare providers, and ultimately, better health outcomes.

Learning Objectives:

  • Explore the benefits of having a section dedicated to patient experience in labeling
  • Understand what would be required to create this new section in labeling
  • Discuss potential challenges of a new PED labeling section