What is an externally-led patient-focused drug development (EL-PFDD) meeting?

Externally-led Patient-Focused Drug Development meetings give FDA and other key stakeholders, including life science companies, researchers, and health care clinicians, an important opportunity to hear directly from patients, their families, caregivers, and patient advocates about:

• The most burdensome symptoms of the condition
• The impact the condition has on people’s daily lives
• Patients’ experiences with currently available treatments.

This input can inform FDA’s decisions and oversight during therapy and device development and during review of a marketing application.

This meeting is being conducted as a parallel effort to FDA’s PFDD initiative to more systematically gather patients’ perspectives on their conditions and available therapies to treat their conditions. Click here to learn more about Externally-led Patient-Focused Drug Development meetings. ^[7]

We will share a series of short videos with more details about the importance of EL-PFDD meetings and ways you can participate in the Let’s Talk Cough meeting.

When and where is the Let’s Talk Cough meeting?

The Let’s Talk Cough meeting will take place on October 28, 2026 (exact time TBA). People with chronic cough and caregivers will come together in person in the Washington, DC area. The meeting will also be livestreamed and anyone can join virtually, whether you are directly affected by chronic cough or working to improve the management and outcomes of chronic cough. The livestream will be available on this webpage on October 28. There is no cost to participate or attend. The recording will also be available soon after the meeting for on-demand viewing.

How can I participate in the Let’s Talk Cough meeting?

Anyone who is affected by chronic cough can join the meeting on October 28. If you are interested in attending in person, please let us know in the sign-up form ^[1]. The livestream will be accessible by all on this webpage on October 28.

Starting a few weeks before the meeting, we will ask for people affected by chronic cough to submit comments online that may be read during the meeting. Comments should respond to questions posed by FDA on topics related to the burdens of living with and managing chronic cough.

Speakers at the meeting will be people affected by chronic cough that represent the diverse ways in which it and its management affect children, teens, and adults over the course of their lives. We will be identifying and confirming speakers over the coming weeks.

Sign up to stay informed ^[1] and learn more about the importance of EL-PFDD meetings and ways you can be involved in the Let’s Talk Cough meeting as the planning progresses.

What is the goal of the Let’s Talk Cough initiative?

People not impacted by chronic cough may not understand or even discredit the impact cough has on daily life. This meeting is our chance to illustrate the burden and unmet needs people with chronic cough experience.

The goal of the Let’s Talk Cough initiative is to provide the U.S. Food and Drug Administration (FDA), medical product developers, clinicians, and academic researchers an opportunity to hear perspectives from people with chronic cough on the health effects and daily impacts of chronic cough, treatment goals, and decision factors considered when seeking out or selecting a clinical trial or treatment.

What topics will the Let’s Talk Cough meeting cover?

At the Let’s Talk Cough meeting, patients and caregivers will answer specific questions provided by the FDA. These questions will focus on understanding:

• Symptoms you experience because of chronic cough
• The impact chronic cough has on daily life and longer-range life goals
• Your chronic cough management regimen and how well it addresses your chronic cough
• How chronic cough and its management may have changed over time
• Meaningful changes that future chronic cough treatments might address
• Attitudes toward participating in clinical trials and barriers you might face

In keeping with the FDA’s mission and areas of responsibility, this meeting will not be an appropriate time to cover some topics that we know are very important. This includes topics that the FDA does not have control over, such as insurance coverage, cost of medications, and proposed healthcare legislation.

How will all our valuable experience be recorded and shared?

The Let’s Talk Cough meeting will be recorded, and the recording will be posted on this webpage following the meeting.

Information shared as part of the initiative will be summarized in the Let’s Talk Cough “Voice of the Patient” report. We will publish this report, submit it to FDA for posting on the agency’s website, and share it broadly. It will be an enduring resource for the chronic cough community to use beyond the Let’s Talk Cough meeting to help with advocacy campaigns, to share the chronic cough lived experience with the general public, or to introduce new researchers to the needs of the chronic cough community.