The Impact of the Orphan Drug Act on the Development and Advancement of Neurological Products for Rare Diseases: A Descriptive Review

2010 ◽  
Vol 88 (4) ◽  
pp. 449-453 ◽  
Author(s):  
K A Burke ◽  
S N Freeman ◽  
M A Imoisili ◽  
T R Coté
Keyword(s):  
Orphan Drug ◽  
Rare Diseases ◽  
Orphan Drug Act ◽  
The Impact

scholarly journals Rare Diseases, Drug Development, and AIDS: The Impact of the Orphan Drug Act

1995 ◽  
Vol 73 (2) ◽  
pp. 231 ◽  
Author(s):  
Peter S. Arno ◽  
Karen Bonuck ◽  
Michael Davis
Keyword(s):  
Drug Development ◽  
Orphan Drug ◽  
Rare Diseases ◽  
Orphan Drug Act ◽  
The Impact

scholarly journals The Orphan Drug Act: An Appropriate Approval Pathway for Treatments of Rare Diseases?

2019 ◽  
Vol 54 (5) ◽  
pp. 283-284 ◽  
Author(s):  
Michael Gabay
Keyword(s):  
Orphan Drug ◽  
Rare Diseases ◽  
Financial Incentives ◽  
Annual Number ◽  
Recent Past ◽  
Regulatory Requirements ◽  
Drug Products ◽  
Orphan Drug Act ◽  
Pharmaceutical Manufacturers ◽  
Financial Benefits

The Orphan Drug Act provides financial incentives to pharmaceutical manufacturers to develop treatments for rare diseases affecting limited patient populations. Since passage of the Act in 1983, the U.S. Food and Drug Administration (FDA) has approved more than 600 orphan drug indications from greater than 450 distinct drug products. The annual number of orphan drug designation approvals has increased significantly in the recent past with much of this increase driven by approval of secondary indications for previously approved treatments. This recent increase has led to concerns regarding the Act as some pharmaceutical manufacturers have reaped outsized financial benefits while avoiding the regulatory requirements and costs associated with nonorphan drug development.

The impact of the Orphan Drug Act on drug discovery

2006 ◽  
Vol 1 (6) ◽  
pp. 521-524 ◽  
Author(s):  
Marlene E Haffner ◽  
Paul D Maher
Keyword(s):  
Drug Discovery ◽  
Orphan Drug ◽  
Orphan Drug Act ◽  
The Impact

scholarly journals The Orphan Drug Act and the Development of Stem Cell-Based Products for Rare Diseases

2010 ◽  
Vol 7 (3) ◽  
pp. 283-287 ◽  
Author(s):  
Scott N. Freeman ◽  
Kathryn A. Burke ◽  
Menfo A. Imoisili ◽  
Timothy R. Coté
Keyword(s):  
Stem Cell ◽  
Orphan Drug ◽  
Rare Diseases ◽  
Orphan Drug Act
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