Regulatory approval pathways for anticancer drugs in Japan, the EU and the US

International Journal of Hematology

Volumn 104, Issue 1, 2016, Pages 73-84

  Nagai, Sumimasa ^a   Ozawa, Keiya ^a  

^a UNIVERSITY OF TOKYO   (Japan)

Author keywords

EMA; FDA; PMDA; Regulation

Indexed keywords

ANTINEOPLASTIC AGENT;

CLINICAL EVALUATION; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; DRUG SAFETY; EUROPE; FOOD AND DRUG ADMINISTRATION; JAPAN; OFF LABEL DRUG USE; REGISTRATION; REVIEW; UNITED STATES; DRUG CONTROL; EUROPEAN UNION; HUMAN; PROCEDURES;

ANTINEOPLASTIC AGENTS; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; EUROPEAN UNION; HUMANS; JAPAN; UNITED STATES;

EID: 84963783385     PISSN: 09255710     EISSN: 18653774     Source Type: Journal    
DOI: 10.1007/s12185-016-2001-7     Document Type: Review

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