CDER Kicks Off Final Phase of OND Reorganization

Regulatory NewsRegulatory News | 18 March 2020 |  By 

OND Director Peter Stein

The reorganization of the FDA’s Office of New Drugs (OND) is nearing the finish line with a final round of changes to formally establish three new offices.

According to an email from OND Director Peter Stein on Monday, Phase IV of the reorganization will formally establish the Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN); the Office of Immunology and Inflammation (OII) and the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM), and the corresponding divisions of Regulatory Operations in the Office of Regulatory Operations (ORO) and Divisions of Pharmacology/Toxicology (Pharm/Tox), and Office of Administrative Operations.    

OCHEN, formed from divisions in the Office of Drug Evaluation I, II, III, and the Office of Hematology and Oncology Products, will be led by director Ellis Unger and deputy director Mary Thanh Hai.

OII, which was created from divisions in the Office of Drug Evaluation II, III and the Office of Antimicrobial Products, will be led by director Julie Beitz. And ORPURM, formed from divisions in the Office of Drug Evaluation III and IV, will be led by acting director Hylton Joffe.

Stein said this last phase of implementation will occur over the next several weeks and divisions operating in “transition” from earlier phases will now operate as part of their new offices.

In addition to announcing more than a dozen other new division leaders in each of these three offices, Stein also said that Hanan Ghantous is the acting director of the Division of Pharm/Tox for Infectious Diseases, John Leighton is the director of the Division of Hematology Oncology Toxicology (DHOT) and Haleh Saber is the deputy director of DHOT.

Last month, Stein sat down for an interview with Focus to further explain the reorganization, noting: “The restructuring was really to make OND more therapeutically aligned and to make the divisions more right-sized. So when I came, there were some divisions that were really huge with broad ranges of responsibility, often coming up to a director and deputy director, but really this huge range coming up to small leadership, which was a challenge. So we tried to right-size the divisions, but I think even more importantly, we wanted to get divisions together that were more disease-focused.”

Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality


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