Navidea Biopharmaceuticals Inc (NAVB)

[biocqr]

George Mills, MD

Director, Division of Medical Imaging and Radiopharmaceutical Drug Products, U.S. Food and Drug Administration


I am the Division Director in the Division of Medical Imaging and Radiopharmaceutical products, which report to the Office of New Drugs within CDER/FDA. My division is responsible for the review and approval of diagnostic imaging drugs and radiolabeled therapeutic oncologic drugs. In my capacity, I direct a staff of 34 professionals involved in the various disciplines of the review of INDs, BLAs, and NDAs.

In my prior 10+ years with FDA, I have served as a medical officer, Team Leader, Branch Chief, and as the Acting Deputy Division Director of the biologics oncology branch/division within CBER and CDER. In these positions, I served as the medical scientific Chief of the Oncology Branch/Division and as a CBER/CDER expert on medical diagnostic imaging and therapeutic radiopharmaceutical oncologic biologics and drugs. In addition, I served as a CBER/CDER expert on the review of radiographic imaging submissions in support of various licensure submissions throughout CBER/CDER.

During my experience in the Oncology Branch/Division, I have performed, directed, and coordinated the work of the professional staff within the Oncology Branch to complete the IND, BLA and NDA clinical, pharmtox, product, and project management reviews as required of the staff. I was responsible for recommending approval and/or rejection of Biologic License Applications (BLAs), supplements, Notices of Claimed Investigational Exception [INDs] and other regulatory actions pertaining to investigational biologic drugs.

Prior to coming to FDA, I was in the private clinical practice of diagnostic/therapeutic Nuclear Medicine and Pathology for 16 years. In the course of my private practice, I participated in various clinical trials with diagnostic and therapeutic biologic products.


http://www.biomarkers.org/staff/mills.html