Are products with an orphan designation for oncology indications different from products for other rare indications? A retrospective analysis of European orphan designations granted between 2002-2012

Orphanet Journal of Rare Diseases

Volumn 12, Issue 1, 2017, Pages

  Pauwels, Kim ^a   Huys, Isabelle ^a   Casteels, Minne ^a   Larsson, Kristina ^b   Voltz, Caroline ^b   Penttila, Karri ^c,d   Morel, Thomas ^a   Simoens, Steven ^a  

^a UNIVERSITY OF LEUVEN   (Belgium)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c Finnish Medicines Agency   (Finland)

^d Savonlinna Central Hospital   (Finland)

Author keywords

Cancer; EMA; Neoplastic disorders; Orphan designation; Orphan medicinal product

Indexed keywords

ORPHAN DRUG; ORPHAN MEDICINAL PRODUCT; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT;

ARTICLE; CLINICAL DEVELOPMENT; COMMERCIAL PHENOMENA; COMPANY SIZE; DRUG DEVELOPMENT; DRUG INDICATION; DRUG MARKETING; EUROPE; GOVERNMENT REGULATION; HEALTH CARE CONCEPTS; HUMAN; MARKETING AUTHORIZATION; MEDICAL SOCIETY; NEOPLASM; ONCOLOGY; ORPHAN DESIGNATION; OTHER RARE CONDITION; PHASE 1 CLINICAL TRIAL (TOPIC); PHYSICAL DISEASE; PRECLINICAL STUDY; RARE NEOPLASTIC DISORDER; RETROSPECTIVE STUDY; RISK BENEFIT ANALYSIS; TREND STUDY; DRUG APPROVAL; DRUG INDUSTRY; DRUG MANUFACTURE; RARE DISEASE;

ANTINEOPLASTIC AGENTS; DRUG APPROVAL; DRUG INDUSTRY; EUROPE; HUMANS; NEOPLASMS; ORPHAN DRUG PRODUCTION; RARE DISEASES; RETROSPECTIVE STUDIES;

EID: 85012868104     PISSN: None     EISSN: 17501172     Source Type: Journal    
DOI: 10.1186/s13023-017-0578-4     Document Type: Article

References (8)

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