EU marketing authorization review of orphan and non-orphan drugs does not differ

Drug Discovery Today

Volumn 18, Issue 19-20, 2013, Pages 1001-1006

  Putzeist, M ^a,b   Mantel Teeuwisse, A K ^a   Llinares, J ^c   Gispen De Wied, C C ^b   Hoes, A W ^d   Leufkens, H G M ^a,b  

^a UTRECHT UNIVERSITY   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c EUROPEAN MEDICINES AGENCY   (United Kingdom)

^d UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

IMIGLUCERASE; ORPHAN DRUG; PIRFENIDONE; PLERIXAFOR; VELAGLUCERASE ALFA;

CLINICAL DEVELOPMENT PLAN; CLINICAL RESEARCH; DRUG APPROVAL; DRUG INDICATION; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; ENZYME THERAPY; EUROPEAN UNION; HUMAN; MEDICAL NEED; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PATIENT MONITORING; PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; RARE DISEASE; REVIEW; RISK BENEFIT ANALYSIS; STEM CELL MOBILIZATION; THROMBOCYTOPENIA; TRANSLATIONAL RESEARCH; TREATMENT OUTCOME;

ANIMALS; DRUG APPROVAL; EUROPEAN UNION; HUMANS; MARKETING; ORPHAN DRUG PRODUCTION; PHARMACEUTICAL PREPARATIONS;

EID: 84884597421     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2013.06.012     Document Type: Review

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