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Informal Discussion of Literature Reviews of Safety and Efficacy Data for PET: 150-Water and 18F-Fluorodopa - July 28, 2000

Date and Time: July 28, 2000, 9 a.m.

Location: Gaithersburg, MD

A discussion between representatives of the Institute for Clinical PET and FDA of the preliminary results of the literature reviews conducted by the Center for Drug Evaluation and Research of the safety and efficacy of two PET products: 15O-water and 18F-fluorodopa. The discussion was open to the public, with time allotted for public comment on the discussion topics. Pre-registration was not necessary to attend this meeting.

 

 

Agenda

Opening Remarks and Welcome Ms. Jane Axelrad, FDA

Opening Remarks Dr. Jorge Barrio, ICP

Presentation of 15O-Water Literature Review Dr. Alfredo Sancho, FDA

Dr. Patricia Love, FDA

Discussion of 15O-Water Literature Review

Presentation of 18F-Fluorodopa Literature Review Dr. Alfredo Sancho, FDA

Dr. Adebayo Laniyonu, FDA

Dr. Ramesh Raman, FDA

Discussion of 18F-Fluorodopa Literature Review

Summary Discussion and Closing Remarks Ms. Jane Axelrad, FDA

 

Participants

 

Institute for Clinical PET

Jorge Barrio, Ph.D., Professor, Department of Molecular and Medical Pharmacology, University of California, Los Angeles

David Brookes, M.D., Hammersmith Hospital, UK

Peter S. Conti, MD, Ph.D., Associate Professor of Radiology, Clinical Pharmacy, and Biomedical Engineering, University of Southern California

Ron Finn, Ph.D., Memorial Sloan Kettering Cancer Center, New York

John Hoffman, M.D., National Cancer Institute

Jennifer Keppler, Executive Director, Institute for Clinical PET

 

Food and Drug Administration - Center for Drug Evaluation and Research

Jane Axelrad, J.D., Associate Director for Policy

Florence Houn, M.D., MPH, Director, Office of Drug Evaluation III

Adebayo Laniyonu, Ph.D., Pharmacology/Toxicology Reviewer, Division of Medical Imaging and Radiopharmaceutical Drug Products

Robert K. Leedham, Jr., R.Ph., Chief, Project Management Staff, Division of Medical Imaging and Radiopharmaceutical Drug Products

Patricia Love, M.D., Director, Division of Medical Imaging and Radiopharmaceutical Drug Products

Ramesh Raman, M.D., Medical Officer, Division of Medical Imaging and Radiopharmaceutical Drug Products

Nakissa Sadrieh, Ph.D., Pharmacology/Toxicology Team Leader, Division of Medical Imaging and Radiopharmaceutical Drug Products

Alfredo Sancho, Ph.D., Clinical Pharmacology and Biopharmaceutics Reviewer, Division of Pharmaceutical Evaluation II