The Oncologist, Vol. 7, No. 2, 167,
April 2002
© 2002 AlphaMed Press
Dr. Grant Williams: New Deputy Director of FDA's Division of Oncology Drug Products
Dr. Grant Williams assumed the position of Deputy Director of the Division of Oncology Drug Products on February 24, 2002. Dr. Williams joined the FDA in 1989 as a Medical Officer and assumed his current position as Oncology Medical Team Leader in 1996.
Prior to joining the FDA, he completed an internship and residency in Internal Medicine and a Hematology/Oncology fellowship at the University of Alabama at Birmingham (UAB). He received his medical degree (AOA, First in Class) at UAB in 1982 and his undergraduate degree (Summa Cum Laude, Phi Beta Kappa) at the University of the South in Sewanee, TN in 1977.
During his tenure at the FDA, Dr. Williams has served as the primary reviewer of over 15 new drug applications (NDAs)/efficacy supplements and as medical team leader for over 20 NDAs and was the medical team leader of the Gleevec NDA that was completed in a record two and one-half months. He has been a mentor to many new medical officers in the Division and has participated on a continuing basis in the FDA Staff College courses (Regulatory Science and Design and Analysis of Clinical Trials). Dr. Williams organized the FDA's 17-course lecture series for new oncology reviewers last year and has chaired the Center for Drug Evaluation and Research (CDER) Oncology Coordinating Committee since its inception last year.
An author of two Center for Biologics Evaluation and Research-CDER oncology guidances (Clinical Data in Marketing Applications; Investigational New Drug Exemptions for Marketed Cancer Drugs/Biological Products), he organized two Oncologic Drugs Advisory Committee meetings on single-patient use of investigational drugs, the Divisional efforts at the FDA's last Department of Oncology Drug Products/ Pharmaceuticals Research and Manufacturers of America dialogue session, and has been an external speaker to both professional and patient advocacy groups. Dr. Williams has demonstrated a clear and demonstrated commitment to the Agency, the Division, and to the public health care mandate to improve oncology health care. Dr. Richard Pazdur, Director of the Division of Oncology Drug Products, said, "In making this selection, I was most impressed with Grant's willingness to approach difficult problems with enthusiasm and flexibility. This characteristic will be requisite in the future as we face novel regulatory challenges based on an ever-increasing understanding of cancer biology."
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Dr. Grant Williams
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