U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Prescription Drug User Fee Amendments
  5. Upcoming EL-PFDD Meetings
  1. Prescription Drug User Fee Amendments

Upcoming EL-PFDD Meetings

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

Cerebral Creatine Deficiency Syndromes

Association for Creatine Deficiencies 

Celeste Graham


January 24, 2023

Pemphigus and Pemphigoid

International Pemphigus and Pemphigoid Foundation

Marc Yale


January 25, 2023

Autoimmune Hepatitis

Autoimmune Hepatitis Association

Erin Anderson


January 27, 2023

Wiskott-Aldrich Syndrome

Wiskott-Aldrich Foundation

Sumathi Iyengar


February 3, 2023

Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia (ARVC/D)

SADS Foundation

Alice Lara


June 20, 2023


To contact FDA’s CDER Patient-Focused Drug Development Program Staff, please email patientfocused@fda.hhs.gov.

To get updates about CDER's Patient-Focused Drug Development programs, subscribe to our free email subscription service using the button at the top of the page.

Back to CDER Patient-Focused Drug Development Homepage.

Back to Top