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Abbreviation : ODA
Long Form : Orphan Drug Act
No. Year Title Co-occurring Abbreviation
2022 Rarely mentioned: how we arrived at the quantitative definition of a rare disease. ---
2021 Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals. FDA
2020 Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018. BPCA, FDA, PREA
2020 Regulatory environment for novel therapeutic development in mitochondrial diseases. ---
2019 Precision Medicines' Impact on Orphan Drug Designation. ---
2017 Direct-to-Consumer Genetic Testing and Orphan Drug Development. DTC
2017 Ethical imperatives of timely access to orphan drugs: is possible to reconcile economic incentives and patients' health needs? FDA
2017 Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs. FDA, HUD, PDC, US
2016 Pharmaceutical expenditure on drugs for rare diseases in Canada: a historical (2007-13) and prospective (2014-18) MIDAS sales data analysis. DRDs, FDA, US
10  2014 Insurance companies' perspectives on the orphan drug pipeline. CEA
11  2012 What the Orphan Drug Act has done lately for children with rare diseases: a 10-year analysis. ---
12  2011 Regulatory considerations for developing drugs for rare diseases: orphan designations and early phase clinical trials. FDA, INDs
13  2010 The impact of the Orphan Drug Act on the development and advancement of neurological products for rare diseases: a descriptive review. ---
14  2009 R&D policy, agency costs and innovation in personalized medicine. ---
15  2008 Market incentives and pharmaceutical innovation. ---
16  2005 Advance price or purchase commitments to create markets for treatments for diseases of poverty: lessons from three policies. APPCs, US
17  2004 Developing treatments for inborn errors: incentives available to the clinician. EU, FDA, IEM, OPD
18  2002 Two decades of orphan product development. ---
19  1995 The economics of orphan drug policy in the US. Can the legislation be improved? ---