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Volumn 7, Issue 5, 2002, Pages 390-392
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Gleeve™ for the treatment of chronic myelogenous leukemia: U.S. Food and Drug Administration regulatory mechanisms, accelerated approval, and orphan drug status
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Author keywords
Accelerated approval regulations; Chronic myelogenous leukemia; Food and Drug Administration; Gleevec; Imatinib mesylate; Orphan drug regulations
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Indexed keywords
IMATINIB;
ORPHAN DRUG;
ANTINEOPLASTIC AGENT;
PIPERAZINE DERIVATIVE;
PYRIMIDINE DERIVATIVE;
BLAST CELL CRISIS;
BLOOD TOXICITY;
CHRONIC MYELOID LEUKEMIA;
DRUG APPROVAL;
DRUG EFFICACY;
FLUID RETENTION;
FOOD AND DRUG ADMINISTRATION;
GASTROINTESTINAL TOXICITY;
HUMAN;
LIVER TOXICITY;
PERIPHERAL EDEMA;
PHILADELPHIA 1 CHROMOSOME;
PRIORITY JOURNAL;
REGULATORY MECHANISM;
SHORT SURVEY;
THROMBOCYTOPENIA;
ARTICLE;
DRUG MANUFACTURE;
LEGAL ASPECT;
UNITED STATES;
ANTINEOPLASTIC AGENTS;
DRUG APPROVAL;
HUMANS;
LEUKEMIA, MYELOID, CHRONIC;
ORPHAN DRUG PRODUCTION;
PIPERAZINES;
PYRIMIDINES;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
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EID: 0036025380
PISSN: 10837159
EISSN: None
Source Type: Journal
DOI: 10.1634/theoncologist.7-5-390 Document Type: Short Survey |
Times cited : (35)
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References (0)
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