Listening to patients: The FDA goes from strength to strength


In seeking guidance on how to improve the regulatory process to enable access to much-needed treatments, who better to listen to than patients and caregivers? They are the stakeholders with the greatest understanding of which therapeutic solutions will help them manage their symptoms and improve their quality of life. With this in mind, the US Food and Drug Administration has developed several programs to encourage the patient voice in drug development and healthcare.

Patient Listening Sessions

Hosted by the FDA’s Office of Patient Affairs (OPA), together with the National Organization for Rare Disorders (NORD) and the Reagan-Udall Foundation, Patient Listening Sessions are small and informal conversations that bring patients/caregivers and researchers together.1 These sessions are aimed at complementing the FDA’s existing patient engagement initiatives.

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