FDA Patient Listening Session

Together with the other global MEF2C organisations, we have recently attended a US Food and Drug Administration (FDA) Patient Listening Session organised by our friends at the MEF2C Foundation (UK) and Rarebird (US).

What is a Patient Listening Session (PLS)?

A PLS is an opportunity for the FDA to hear from parents and carers of a loved one with MCHS. It’s a way to educate the FDA about the condition as part of the regulatory journey in the US including to convey the medical needs of those with MCHS which justify new therapeutics. You can read more about PLSs here - Some more info here https://www.fda.gov/patients/learn-about-fda-patient-engagement/fda-patient-listening-sessions 

What was our role in the PLS?

We attended the PLS in a listening capacity only to understand this part of the regulatory process in the US and show our support for the need for new therapeutics to make a difference to the lives of individuals affected by MCHS. We understand a non confidential summary of the PLS will be published by the FDA and made available online. We’ll share this on our news page when it becomes available.