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