To promote transparency and communication, FDA is sharing a list of disease areas where a letter of intent (LOI) has been submitted and ongoing plans exist for a future Externally-Led PFDD meeting. While multiple organizations may be working together, the organizations listed below are the primary points of contact for any questions regarding their EL-PFDD meeting.
FDA does not conduct Externally-Led PFDD meetings and a listing on this webpage does not reflect endorsement.
|
Disease or Condition |
Organization Submitting LOI |
Organization Contact |
Anticipated Meeting Date |
|---|---|---|---|
| Classic Congenital Adrenal Hyperplasia (CAH) | CARES Foundation |
Dina Matos |
October 1, 2024 |
| Lupus Nephritis (LN) | National Kidney Foundation |
David Feldman |
October 11, 2024 |
| Dementia with Lewy Bodies (DLB) | Lewy Body Dementia Association |
Glorieuse Norzea |
October 15, 2024 |
| Sarcoidosis | Foundation for Sarcoidosis Research |
Tricha Shivas |
October 28, 2024 |
| Pre-symptomatic and Early to Mid-stage Adult Onset of Huntington’s Disease (HD) | Huntington’s Disease Society of America (HDSA) |
Phyllis Foxworth |
November 13, 2024 |
|
Angelman Syndrome |
Foundation for Angelman Syndrome Therapeutics (FAST) and the Angelman Syndrome Foundation (ASF) |
Amanda Moore and Ryan Fischer |
January 29, 2025 |
|
Autoimmune Pulmonary Alveolar Proteinosis (aPAP) |
National Organization for Rare Disorders (NORD) |
NORD |
February 5, 2025 |
|
Phenylketonuria (PKU) |
National PKU Alliance (NPKUA) |
Catherine Warren |
May 8, 2025 |
Questions?
To contact FDA’s CDER Patient-Focused Drug Development Program Staff, please email patientfocused@fda.hhs.gov.
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Back to CDER Patient-Focused Drug Development Homepage.
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Content current as of:
09/12/2024
