Division of Medical Imaging and Hematology Products Presentations
FDA Staff Presentations at the Annual Society of Nuclear Medicine Meeting
Imaging Submissions to FDA: Consultative review process [PDF], Tiffany Brown, M.P.H.
Imaging Biomarkers and Imaging Standardization [PDF], Alexander Gorovets, M.D.
Highlights of Standard Meetings with the Medical Imaging Division [PDF], Kyong “Kaye” Kang, Pharm.D.
Chemistry, Manufacturing and Controls (CMC) for PET Drug Products [PDF], Ravindra K. Kasliwal, Ph.D.
Exploratory IND Studies: Pre-clinical Requirements [PDF], Tushar Kokate, Ph.D.
Implementation of the Exploratory IND: Medical Imaging Division Reorganization [PDF], George Mills, M.D., M.B.A.
The Administrative Process of Submitting Positron Emission Tomography (PET) Drug Applications [PDF], Thuy Nguyen, M.P.H.
The Radioactive Drug Research Committee (RDRC): A 2006 Update [PDF], Orhan H. Suleiman MS, PhD, FAAPM
The Study of Radioactive Drugs in Human Subjects: Radioactive Drug Research Committee (RDRC) versus Investigational New Drug (IND) [PDF] Renee Tyson