Navigating through orphan medicinal product regulations in EU and US - Similarities and differences

Regulatory Toxicology and Pharmacology

Volumn 71, Issue 1, 2015, Pages 63-67

  Tiwari, Jyoti ^a  

^a Glenmark Pharmaceuticals Limited   (India)

Author keywords

Committee for orphan medicinal products; Office of orphan products development; Orphan designation; Orphan drug act; Orphan drugs; Rare diseases

Indexed keywords

GENERIC DRUG; ORPHAN DRUG;

ARTICLE; COMPARATIVE STUDY; DRUG CONTROL; DRUG MANUFACTURE; DRUG MARKETING; DRUG USE; EUROPE; GOVERNMENT REGULATION; HUMAN; LEGAL PROCEDURE; POLICY; RARE DISEASE; UNITED STATES; DRUG LEGISLATION; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; LEGISLATION AND JURISPRUDENCE; RARE DISEASES;

EUROPEAN UNION; GOVERNMENT AGENCIES; HUMANS; LEGISLATION, DRUG; ORPHAN DRUG PRODUCTION; RARE DISEASES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84919820169     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2014.11.006     Document Type: Article

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