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

celeste@creatineinfo.org

January 24, 2023

Pemphigus and Pemphigoid

International Pemphigus and Pemphigoid Foundation

Marc Yale

marc@pemphigus.org

January 25, 2023

Autoimmune Hepatitis

Autoimmune Hepatitis Association

Erin Anderson

eanderson@aihep.org

January 27, 2023

Wiskott-Aldrich Syndrome

Wiskott-Aldrich Foundation

Sumathi Iyengar

Sumathi.iyengar@wiskott.org

February 3, 2023

Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia (ARVC/D)

SADS Foundation

Alice Lara

alice@sads.org

June 20, 2023

Questions?

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