Orphan drug development: Incentives under the orphan drug act:
After describing the intellectual property and regulatory environment for orphan drugs in the United States, this thesis compares the investment decisions in the orphan drug market with the larger pharmaceutical industry. A series of case studies trace the development paths of different orphan produ...
Gespeichert in:
1. Verfasser: | |
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Format: | Abschlussarbeit Buch |
Sprache: | English |
Veröffentlicht: |
Trinity College Digital Repository
2015
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Schriftenreihe: | Senior theses and projects
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Schlagworte: | |
Online-Zugang: | Volltext |
Zusammenfassung: | After describing the intellectual property and regulatory environment for orphan drugs in the United States, this thesis compares the investment decisions in the orphan drug market with the larger pharmaceutical industry. A series of case studies trace the development paths of different orphan products using information collected through the Food and Drug Administration (FDA) Approved Drug Product and Orphan Drug Product Designation Databases. In addition to this analysis, difference-in-differences estimates calculated using annual revenues compare the relative success of different orphan products under the current incentive system. This study finds that partial orphan drugs are associated with larger revenue growth. Lastly, this study proposes several policy prescriptions as alternatives to the current legislation |
Beschreibung: | iv, 90 Seiten |
Internformat
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520 | |a After describing the intellectual property and regulatory environment for orphan drugs in the United States, this thesis compares the investment decisions in the orphan drug market with the larger pharmaceutical industry. A series of case studies trace the development paths of different orphan products using information collected through the Food and Drug Administration (FDA) Approved Drug Product and Orphan Drug Product Designation Databases. In addition to this analysis, difference-in-differences estimates calculated using annual revenues compare the relative success of different orphan products under the current incentive system. This study finds that partial orphan drugs are associated with larger revenue growth. Lastly, this study proposes several policy prescriptions as alternatives to the current legislation | ||
650 | 4 | |a Orphan Drugs | |
650 | 4 | |a Market Exclusivity | |
650 | 4 | |a Rare Disease | |
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Datensatz im Suchindex
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author | Smith, Sara H. D. |
author_facet | Smith, Sara H. D. |
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author_sort | Smith, Sara H. D. |
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series2 | Senior theses and projects |
spelling | Smith, Sara H. D. Verfasser aut Orphan drug development: Incentives under the orphan drug act by Sara H D Smith Trinity College Digital Repository 2015 iv, 90 Seiten txt rdacontent n rdamedia nc rdacarrier Senior theses and projects Dissertation Trinity College Hartford, Conn. 2015 After describing the intellectual property and regulatory environment for orphan drugs in the United States, this thesis compares the investment decisions in the orphan drug market with the larger pharmaceutical industry. A series of case studies trace the development paths of different orphan products using information collected through the Food and Drug Administration (FDA) Approved Drug Product and Orphan Drug Product Designation Databases. In addition to this analysis, difference-in-differences estimates calculated using annual revenues compare the relative success of different orphan products under the current incentive system. This study finds that partial orphan drugs are associated with larger revenue growth. Lastly, this study proposes several policy prescriptions as alternatives to the current legislation Orphan Drugs Market Exclusivity Rare Disease The Orphan Drug Act FDA Business Law, Public Responsibility, and Ethics Food and Drug Law Intellectual Property Law Law and Economics Pharmacoeconomics and Pharmaceutical Economics (DE-588)4113937-9 Hochschulschrift gnd-content http://digitalrepository.trincoll.edu/cgi/viewcontent.cgi?article=1500&context=theses Verlag kostenfrei Volltext |
spellingShingle | Smith, Sara H. D. Orphan drug development: Incentives under the orphan drug act Orphan Drugs Market Exclusivity Rare Disease The Orphan Drug Act FDA Business Law, Public Responsibility, and Ethics Food and Drug Law Intellectual Property Law Law and Economics Pharmacoeconomics and Pharmaceutical Economics |
subject_GND | (DE-588)4113937-9 |
title | Orphan drug development: Incentives under the orphan drug act |
title_auth | Orphan drug development: Incentives under the orphan drug act |
title_exact_search | Orphan drug development: Incentives under the orphan drug act |
title_full | Orphan drug development: Incentives under the orphan drug act by Sara H D Smith |
title_fullStr | Orphan drug development: Incentives under the orphan drug act by Sara H D Smith |
title_full_unstemmed | Orphan drug development: Incentives under the orphan drug act by Sara H D Smith |
title_short | Orphan drug development: Incentives under the orphan drug act |
title_sort | orphan drug development incentives under the orphan drug act |
topic | Orphan Drugs Market Exclusivity Rare Disease The Orphan Drug Act FDA Business Law, Public Responsibility, and Ethics Food and Drug Law Intellectual Property Law Law and Economics Pharmacoeconomics and Pharmaceutical Economics |
topic_facet | Orphan Drugs Market Exclusivity Rare Disease The Orphan Drug Act FDA Business Law, Public Responsibility, and Ethics Food and Drug Law Intellectual Property Law Law and Economics Pharmacoeconomics and Pharmaceutical Economics Hochschulschrift |
url | http://digitalrepository.trincoll.edu/cgi/viewcontent.cgi?article=1500&context=theses |
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