Efficacy considerations for U.S. food and drug administration approval of diagnostic radiopharmaceuticals

Journal of Nuclear Medicine

Volumn 54, Issue 8, 2013, Pages 1479-1484

  Gorovets, Alexander ^a   Marzella, Louis ^a   Rieves, Dwaine ^a   Yang, Lucie ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

FDA; Medical imaging drugs; Molecular imaging; Radiopharmaceuticals

Indexed keywords

(3 IODOBENZYL)GUANIDINE I 123; AMMONIUM NITRATE; BIOLOGICAL PRODUCT; CHOLINE C 11; FANOLESOMAB TC 99M; FLORBETAPIR F 18; FLUORIDE SODIUM; FLUORODEOXYGLUCOSE F 18; IOFLUPANE I 123; RADIOPHARMACEUTICAL AGENT; SODIUM FLUORIDE F 18;

ARTICLE; DIAGNOSTIC IMAGING; DRUG APPROVAL; DRUG EFFICACY; DRUG LABELING; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; POSITRON EMISSION TOMOGRAPHY; PRESCRIPTION; PRIORITY JOURNAL; UNITED STATES;

FDA; MEDICAL IMAGING DRUGS; MOLECULAR IMAGING; RADIOPHARMACEUTICALS;

BIOLOGICAL AGENTS; DRUG APPROVAL; HUMANS; PRESCRIPTION DRUGS; RADIOPHARMACEUTICALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84881415543     PISSN: 01615505     EISSN: None     Source Type: Journal    
DOI: 10.2967/jnumed.112.117804     Document Type: Article

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