What is a PFDD Meeting?
According to the U.S. Food and Drug Administration (FDA), the patient perspective is critical in helping the FDA understand the context in which regulatory decisions are made for new drugs. This input can inform DDA’s decisions and oversight both during drug development and during our review of a marketing application.
The patient-Focused Drug Development (PFDD) initiative aims to obtain the patient perspective on specific disorders and their available treatments in a more systematic way.
Externally-Led Patient-Focused Drug Development (EL-PFDD) meetings provide opportunities for patients, their relatives, and caregivers to share critical insights into how their condition affects their daily lives. Receiving insight into the experiences of patients is vital insight for the U.S. Food and Drug Administration (FDA), researchers, medical developers, and health care providers.
The goals of this EL-PFDD meeting are to provide physicians, pharmaceutical companies and the FDA with a robust understanding of patients’ and caregivers’ experiences with Acromegaly. This includes how individuals with Acromegaly view their quality of life, what aspects of the disease are most problematic for them, and what actions they currently perform to treat and cope with this disease. The results of this meeting will be shared publicly in a “Voice of the Patient” report in an effort to inform the development of potential therapeutics that are impactful to patients living with Acromegaly.
Why Is it Important?
The PFDD meeting helps the DFDA improve their understanding of Acromegaly from the patient perspective. According to Acromegaly Community, some acromegaly patients recently participated in the AcroQol, a tool used in the clinical trials to determine the quality of life of Acromegaly patients.
The results were surprising and enlightening. They showed that the quality of life of a typical patient may be poor and does not always get addressed by medical teams. This meeting aims to further understand how treatments relate to the quality of life.
Voice of the Patient
The “Voice of the Patient” report will be completed following the meeting by an attending medical writer.
Who will attend?
Patients, treating physicians, pharmaceutical companies that have approved medicines or have medicines in the pipeline for acromegaly treatment and the FTA. The following FTA divisions will also be in attendance: Endocrine, Tumor and Rare Disease.
Online streaming, polling, and chat will be available for those unable to attend, ensuring all stakeholder voices will be heard and their questions addressed. The meeting will be recorded for future use.
To learn more about this event and to register, visit The Externally-Led Patient-Focused Drug Development Meeting (El-PFDD) for Acromegaly page here: EL-Patient Focused Drug Development (PFDD) Meeting
Update – Postponed
Originally scheduled to be held on April 28, 2020, this event has been postponed as a precautionary measure in compliance with the COVID19 shelter in place order. The placeholder (not confirmed) date for this momentous occasion is set for October 2020. Stay tuned and subscribe to receive updates for this and future Acromegaly related news.