Efforts to develop orphan drugs: The FDA experience

Pharmaceuticals Policy and Law

Volumn 12, Issue 1-2, 2010, Pages 53-55

  Ulrich, Linda C ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

FDA; office of orphan products development; orphan designation; orphan drug act

Indexed keywords

ORPHAN DRUG;

DEVICE; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; LAW; PRIORITY JOURNAL; RARE DISEASE; SHORT SURVEY;

EID: 78049397761     PISSN: 13892827     EISSN: None     Source Type: Journal    
DOI: 10.3233/PPL-2010-0266     Document Type: Short Survey

References (2)

1. Code ofFederal Regulations. Sections 316 and 814.100-814.126.
2. www.fda.gov/orphan.