A rational regulatory approach for positron emission tomography imaging probes: From "first in man" to NDA approval and reimbursement

Molecular Imaging and Biology

Volumn 6, Issue 6, 2004, Pages 361-367

  Barrio, Jorge R ^a   Marcus, Carol S ^a   Hung, Joseph C ^b   Keppler, Jennifer S ^c  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b MAYO CLINIC   (United States)

^c CTI Molecular Technologies Inc   (United States)

Author keywords

FDA; Molecular imaging probes; Radiation Drug Research Committee (RDRC); Regulation

Indexed keywords

FLUORODEOXYGLUCOSE; FLUORODEOXYGLUCOSE F 18; RADIOACTIVE MATERIAL; RADIOPHARMACEUTICAL AGENT;

ARTICLE; CLINICAL TRIAL; COMMERCIAL PHENOMENA; COST CONTROL; DIAGNOSTIC IMAGING; DRUG APPROVAL; DRUG EFFICACY; DRUG INDICATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; DRUG SCREENING; DRUG USE; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL LITERATURE; MOLECULAR PROBE; NUCLEAR MEDICINE; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; REIMBURSEMENT; RISK ASSESSMENT; TIME MANAGEMENT;

ANIMALS; DRUG APPROVAL; HUMANS; POSITRON-EMISSION TOMOGRAPHY; RISK ASSESSMENT; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 10244245098     PISSN: 15361632     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.mibio.2004.09.003     Document Type: Article

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