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Externally Led Patient-Focused Drug Development

The primary goal of this virtual (online) meeting, which was held on June 9, 2020, was to hear directly from patients about their perspectives on living with chronic hepatitis B and their experiences with treatments to improve the development of new drugs in the research pipeline. The patient perspective is critical in helping the U.S. Food and Drug Administration (FDA) understand the context in which regulatory decisions are made for new drugs. This input will inform FDA’s decisions and oversight both during drug development and during its review of new treatments.

The meeting format was very interactive with more than 650 attendees and 300-plus comments submitted. The discussion covered current and future hepatitis B treatments. We heard directly from patients, in their own voices, about their perspectives on living with the disease and hopes for clinical trials and treatments.

There was a live Q&A with the audience, as you can see in the official recording. You can view it by clicking on the arrow in the image below.

Download the full report here.

Download the full meeting transcript here.

Download all submitted e-mail comments here.

The FDA has reviewed and posted the report on its External Resources and Information Related to Patients’ Experience page.