scholarly journals Combined assessment of early and late‐phase outcomes in orphan drug development

2021 ◽  
Author(s):  
Konstantinos Pateras ◽  
Stavros Nikolakopoulos ◽  
Kit C. B. Roes
Keyword(s):  
Drug Development ◽  
Orphan Drug ◽  
Late Phase ◽  
Orphan Drug Development

scholarly journals New Financial and Research Models for Pediatric Orphan Drug Development: Focus on the NCATS TRND Program

2014 ◽  
Vol 28 (1) ◽  
pp. 1-6 ◽  
Author(s):  
John Shen ◽  
Gurmit Grewal ◽  
Andre M. Pilon ◽  
John C. McKew
Keyword(s):  
Drug Development ◽  
Orphan Drug ◽  
Orphan Drug Development

Orphan Drugs: The Question of Products Liability

1985 ◽  
Vol 10 (4) ◽  
pp. 491-513
Author(s):  
Susan F. Scharf
Keyword(s):  
Drug Development ◽  
Orphan Drug ◽  
Rare Diseases ◽  
Tort Law ◽  
Orphan Drugs ◽  
Products Liability ◽  
Liability Law ◽  
Design Defect ◽  
Liability Costs ◽  
Orphan Drug Development

AbstractOrphan drugs, essential for die treatment of persons widi rare diseases, generally are unprofitable for manufacturers to develop and market. While congressional and administrative efforts to promote die development of orphan drugs have met widi modest success, application of products liability doctrine to orphan drug sponsors could subvert those efforts. This Note describes die provisions of die Orphan Drug Act and analyzes products liability law with respect to orphan drug litigation. It argues that die goals of tort law support the imposition of liability for design defect, failure to warn and negligence in testing. Finally, die Note acknowledges diat liability costs create disincentives for orphan drug development and suggests mechanisms for reducing manufacturers’ liability concerns.

Orphan drug development: the increasing role of clinical pharmacology

2019 ◽  
Vol 46 (5) ◽  
pp. 395-409 ◽  
Author(s):  
Mariam A. Ahmed ◽  
Malek Okour ◽  
Richard Brundage ◽  
Reena V. Kartha
Keyword(s):  
Clinical Pharmacology ◽  
Drug Development ◽  
Orphan Drug ◽  
Orphan Drug Development

Rare lung disease and orphan drug development

2013 ◽  
Vol 1 (6) ◽  
pp. 479-487 ◽  
Author(s):  
Paolo Spagnolo ◽  
Roland M du Bois ◽  
Vincent Cottin
Keyword(s):  
Drug Development ◽  
Lung Disease ◽  
Orphan Drug ◽  
Orphan Drug Development
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