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Journal Article
J Health Polit Policy Law (1998) 23 (2): 265–290.
Published: 01 April 1998
...Mae Thamer; Niall Brennan; Rafael Semansky Six countries—Canada, France, Japan, Sweden, the United Kingdom, and the United States—were studied to compare public policies affecting the development and marketing of pharmaceuticals for rare diseases (i.e., orphan drugs). Information was obtained from...
Journal Article
J Health Polit Policy Law (2024) 49 (5): 911–938.
Published: 01 October 2024
... health. Methods: The authors conduct a case study of the political factors influencing the adoption of the EU's Biotechnology Directive 98/44/EC and Orphan Medicines Regulation 141/2000. Findings: The European Commission (EC) generally framed both of its proposals around economical and biomedical...
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in The EU as a Political Determinant of Global Health: The Case of Research and Development Incentives for Orphan Medicines and Biotechnology
> Journal of Health Politics, Policy and Law
Published: 01 October 2024
Figure 2 Timeline of the legislative processes for the Biotechnology Directive and the Orphan Regulation.
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Journal Article
J Health Polit Policy Law (2022) 47 (5): 583–607.
Published: 01 October 2022
... the “orphan drug” designation (FDA 2019 : 10) granted to therapies addressing diseases affecting fewer than 200,000 people (FDA n.d. ). Compare this with 2008, when just five of 21 new molecular entities were considered orphan drugs (Hughes 2009 : 95). One report calculates that the percentage of orphan...
Journal Article
J Health Polit Policy Law (2022) 47 (6): 649–672.
Published: 01 December 2022
... endpoints, we extracted the correlations reported. For studies relating to regulatory pathways, we extracted the percentage of approvals associated with any of the following programs or pathways: Orphan Drug Act, fast track, priority review, accelerated approval, and breakthrough therapy. We recorded...
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Includes: Supplementary data
Journal Article
J Health Polit Policy Law (2022) 47 (6): 629–648.
Published: 01 December 2022
... compounds, implants or devices, products approved only for hospitalized patients, or products with less than $1 billion in average annual sales approved for a nonpediatric orphan indication by the Food and Drug Administration. 1 We also restrict our analysis to the 2009–2019 period, as SSR Health reports...
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Includes: Supplementary data
Journal Article
J Health Polit Policy Law (1998) 23 (6): 1037–1039.
Published: 01 December 1998
...:395–396
Thamer, Mae, Niall Brennan, and Rafael Semansky. A Cross-National Comparison of Orphan Drug Policies:
Implications for the U.S. Orphan Drug Act, 2:265–290
Vining, Aidan. See Schwindt
Weissert, Carol S., and Susan L. Silberman. Sending a Policy Signal: State Legislatures, Medical...
Journal Article
J Health Polit Policy Law (2022) 47 (4): 523–526.
Published: 01 August 2022
... of it, is hard to justify as necessary to encourage useful innovation (27, 52–53, 68). As she points out, compromises made to enact legislation often provide much bigger loopholes than might have been expected (69–70). For example, provisions for higher prices for “orphan” drugs have been manipulated in all...
Journal Article
J Health Polit Policy Law (1995) 20 (1): 230–232.
Published: 01 February 1995
... effect of the HIV/AIDS epidemic.
Carol Levine, The Orphan Project
Reference
Lightman, Alan. 1993. Einstein’s Dreams. New York: Pantheon. ...
Journal Article
J Health Polit Policy Law (2008) 33 (2): 325–327.
Published: 01 April 2008
... not far from the costs that companies them-
selves report in their audited IRS forms for tax credits on orphan drug
trials. DiMasi, Hansen, and Grabowski would have you believe I wrote
that “$300 million is the median R&D cost per approved new drug for our
data” (emphasis added); but $300 million...
Journal Article
J Health Polit Policy Law (2012) 37 (4): 729–732.
Published: 01 August 2012
... of other important
health policy issues that are not included here that could have constituted
discrete chapters . . . home care and long- term care; Aboriginal health
care and policy focusing on other vulnerable or underrepresented groups;
rural health care; bioethics; orphan diseases; and so...
Journal Article
J Health Polit Policy Law (1998) 23 (2): 419–422.
Published: 01 April 1998
...-
lications have focused on vulnerable populations such as those with orphan condi-
422 Journal of Health Politics, Policy and Law
tions (as presented in this issue), patients ineligible for Medicare and/or Medicaid,
and the foreign-born population. Dr. Thamer received her doctorate degree in bio...
Journal Article
J Health Polit Policy Law (1995) 20 (3): 824–827.
Published: 01 June 1995
... Copyright © 1995 by Duke University Press 1995 824 Journal of Health Politics, Policy and Law
Books Received
AIDS
AIDS and the New Orphans: Coping with Death. Barbara 0.Dane and Carol Levine,
eds. Westport, CT: Greenwood Publishing...
Journal Article
J Health Polit Policy Law (1978) 3 (1): 136–139.
Published: 01 February 1978
..., guardianship of physically
incapacitated patients, estate administration for neglected decedents and
financial management for orphaned children. The U .S. Senate Special
Committee on Aging in July 1977 urged the establishment of a public
fiduciary office in all states and provided model...
Journal Article
J Health Polit Policy Law (2007) 32 (5): 895–913.
Published: 01 October 2007
... for orphan drug candidates and $33.6
million for all orphan NMEs, an average of $22.5 million (Love 2003:
7 – 8). Clinical trials for orphan drug candidates may differ in some ways
but not by a lot. In sum, the CBO had good reason to inform Congress that
R&D costs based on official and audited...
Journal Article
J Health Polit Policy Law (2003) 28 (4): 615–658.
Published: 01 August 2003
... . Government Actions in Times of Crisis: Lessons from the History of Drug Regulation. Journal of Social History 18 (3): 433 -438. Thamer, M., N. Brennan, and R. Semansky. 1998 . A Cross-National Comparison of Orphan Drug Policies: Implications for the U.S. Orphan Drug Act. Journal of Health Politics...
Journal Article
J Health Polit Policy Law (1995) 20 (1): 265–269.
Published: 01 February 1995
... and her masters of public health from the University of North Carolina at Chapel
Hill in 1979.
Carol Levine is executive director of The Orphan Project: Families and Children in
the AIDS Epidemic, a research project in New York City.
Antonia Maioni is an assistant professor in the Department...
Journal Article
J Health Polit Policy Law (2006) 31 (4): 873–877.
Published: 01 August 2006
.... Schwartz, and Leslie Rudd, eds. New York: Guilford, 2005. 308
pp. $35.00 cloth.
History and Humanities
The Death of a Disease: A History of the Eradication of Poliomyelitis. Bernard Sey-
tre and Mary Shaffer. Piscataway, NJ: Rutgers University Press, 2005. 168 pp. $22.95
paper.
Widows and Orphans...
Journal Article
J Health Polit Policy Law (1994) 19 (3): 683–688.
Published: 01 June 1994
...: Evaluation and Outreach.
Edited by Dennis G. Fisher and Richard H. Needle. Binghamton, NY: Harrington
Park Press, 1993. 223 pp. $17.95 paper.
A Death in the Family: Orphans of the HIV Epidemic. Edited by Carol Levine. New
York United Hospital Fund, 1993. 176 pp. $10.00 paper.
Musesfrom Chaos...
Journal Article
J Health Polit Policy Law (2021) 46 (1): 93–116.
Published: 01 February 2021
... committees: the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee for Medicinal Products for Veterinary Use (CVMP), the Committee for Orphan Medicinal Products (COMP), the Committee on Herbal Medicinal Products (HMPC), the Committee...
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