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Jul. 23, 2015

TOPIC: Uncategorized

NORD Issues Statement on FDA’s New Associate Director for Rare Diseases

Posted by Jennifer Huron

The following statement was issued by Peter L. Saltonstall, President and CEO of the National Organization for Rare Disorders (NORD), on today’s announcement that Jonathan C. Goldsmith, MD, FACP, will lead the Rare Diseases Program in the Center for Drug Evaluation and Research (CDER) Office of New Drugs at the Food and Drug Administration (FDA).

NORD congratulates Jonathan C. Goldsmith, MD, FACP in being named permanent Associate Director of the Rare Diseases Program in the CDER Office of New Drugs at the Food and Drug Administration (FDA).  NORD helped to establish this office at the FDA five years ago to bring awareness and support to the rare disease community.  In the time since, the number of FDA-approved treatments for rare diseases has increased.  We look forward to continuing our constructive relationship with the FDA and to working with Dr. Goldsmith in his new permanent role.

The following email was received today by NORD from Dr. John Jenkins, Director, CDER Office of New Drugs, FDA,  announcing the naming of Jonathan Goldsmith as permanent Associate Director for the Rare Diseases Program in the Office of New Drugs Immediate Office:

I am pleased to announce the appointment of Jonathan C. Goldsmith, MD, FACP as permanent Associate Director for the Rare Diseases Program in the OND Immediate Office.  The Rare Diseases Program facilitates, supports and accelerates the development of drug and biologic products for the treatment of patients with rare disorders.  This mission is addressed through coordinating the development of CDER policies, procedures and training; enhancing the science-based approach to rare diseases product regulation; working collaboratively with stakeholders, and promoting consistency and innovation in review. 

Jonathan joined the Rare Diseases Program in 2014.  Jonathan is a board certified hematologist.  He obtained his medical degree at New York University, completed his internship and residency in internal medicine at the Vanderbilt University Hospitals, and completed his fellowship training in hematology at the University of North Carolina, Chapel Hill.  Jonathan’s career path has been focused upon patients and families affected by rare diseases.  He held academic appointments at the University of Iowa College of Medicine, the University of Nebraska Medical Center, and the University of Southern California/Childrens Hospital Los Angeles at the Assistant Professor, Associate Professor and Professor levels.  He has also worked in regulated industry as a Senior Director and Vice President for Clinical Affairs at three firms helping to bring several bio-therapeutics and one medical device to market.  He also served as the Vice President Medical Affairs/Interim  President of the Immune Deficiency Foundation, Towson, MD and later as the Deputy Director, Office of Blood Research and Review/CBER/FDA.  Prior to joining CDER, he was the Deputy Branch Chief for the Blood Diseases Branch of the Division of Blood Diseases and Review/NHLBI/NIH.

Please join me in welcoming Jonathan to his new position.

John Jenkins, MD

(end of email)

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