FDA to Host Patient-Focused Drug Development Public Meeting for Long Covid

The US Food and Drug Administration (FDA) is hosting a virtual public meeting on Patient-Focused Drug Development for Long Covid on Tuesday, April 25th, 2023, from 10 a.m. to 4:00 p.m. ET.  It will be conducted with live translation in both English and Spanish.

Patient-Focused Drug Development meetings are important and infrequent opportunities for patients to provide direct input to the FDA, as well as for the FDA to obtain patient and patient representative input on several aspects related to a disease. ME/CFS was one of the earliest diseases to benefit from the concept of including patients in this process, approximately a decade ago.

This meeting will focus on Long Covid, how it affects daily life, symptoms that matter most to patients, current approaches to treating Long Covid, and considerations for clinical trial participation.

Solve M.E. encourages individuals in our community with Long Covid, family members, advocates, caregivers, and other stakeholders to participate in the live webcast. Register here and find more information on the discussion questions and meeting format, and find more information on FDA’s website.

Patients or caregivers who are willing to share their experiences as part of a panel conversation are asked to indicate their willingness as part of registration. They will then be directed to send a short summary of their responses to the discussion questions to PatientFocused@fda.hhs.gov.

Find event flyers below:

 

Ahead of the FDA’s PFDD for Long Covid, Solve M.E. will host a webinar on March 30th from 11- 12 pm PT / 2-3 pm ET to help educate our community about this important event.

This is a unique opportunity to share stories of living with Long Covid, as well as experiences with treatments, with important decision-makers at the FDA. Though Solve is not involved in the planning of the PFDD meeting, we have invited two former FDA officials who are experts in this area to help prepare our community for this important day.

Register for the March 30 webinar “How to Make an Impact at the FDA’s Drug Development Meeting for Long Covid” here.

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