Drug and country characteristics associated with global approval and launch of FDA-approved novel therapeutics.

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Title: Drug and country characteristics associated with global approval and launch of FDA-approved novel therapeutics.
Authors: Fu M; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Department of Internal Medicine, Yale School of Medicine, New Haven, CT 06520, United States.; International Research Center for Medicinal Administration, Peking University, Beijing 100191, China., Wallach JD; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA 30322, United States., So AD; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Innovation + Design Enabling Access (IDEA) Initiative, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, United States., Doernberg H; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, United States., Li X; Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing 100191, China., Guan X; International Research Center for Medicinal Administration, Peking University, Beijing 100191, China.; Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing 100191, China., Ramachandran R; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Department of Internal Medicine, Yale School of Medicine, New Haven, CT 06520, United States.; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT 06510, United States., Ross JS; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Department of Internal Medicine, Yale School of Medicine, New Haven, CT 06520, United States.; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT 06510, United States.; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT 06520, United States.
Source: Health affairs scholar [Health Aff Sch] 2026 Jul 10; Vol. 4 (7), pp. qxag181. Date of Electronic Publication: 2026 Jul 10 (Print Publication: 2026).
Publication Type: Journal Article
Journal Info: Publisher: Oxford University Press on behalf of Project HOPE - The People-To-People Health Foundation, Inc Country of Publication: England NLM ID: 9918627882906676 Publication Model: eCollection Cited Medium: Internet ISSN: 2976-5390 (Electronic) Linking ISSN: 29765390 NLM ISO Abbreviation: Health Aff Sch Subsets: PubMed not MEDLINE
Database: MEDLINE Ultimate
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  Data: Drug and country characteristics associated with global approval and launch of FDA-approved novel therapeutics.
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  Data: <searchLink fieldCode="AU" term="%22Fu+M%22">Fu M</searchLink>; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Department of Internal Medicine, Yale School of Medicine, New Haven, CT 06520, United States.; International Research Center for Medicinal Administration, Peking University, Beijing 100191, China.<br /><searchLink fieldCode="AU" term="%22Wallach+JD%22">Wallach JD</searchLink>; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA 30322, United States.<br /><searchLink fieldCode="AU" term="%22So+AD%22">So AD</searchLink>; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Innovation + Design Enabling Access (IDEA) Initiative, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, United States.<br /><searchLink fieldCode="AU" term="%22Doernberg+H%22">Doernberg H</searchLink>; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, United States.<br /><searchLink fieldCode="AU" term="%22Li+X%22">Li X</searchLink>; Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing 100191, China.<br /><searchLink fieldCode="AU" term="%22Guan+X%22">Guan X</searchLink>; International Research Center for Medicinal Administration, Peking University, Beijing 100191, China.; Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing 100191, China.<br /><searchLink fieldCode="AU" term="%22Ramachandran+R%22">Ramachandran R</searchLink>; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Department of Internal Medicine, Yale School of Medicine, New Haven, CT 06520, United States.; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT 06510, United States.<br /><searchLink fieldCode="AU" term="%22Ross+JS%22">Ross JS</searchLink>; Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT 06520, United States.; Department of Internal Medicine, Yale School of Medicine, New Haven, CT 06520, United States.; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT 06510, United States.; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT 06520, United States.
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              Text: 2026 Jul 10
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