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Connected health in US, EU, and China: opportunities to accelerate regulation of connected health technologies to optimize their role in medicines development.
Front Med (Lausanne). 2023 Aug 7;10:1248912. doi: 10.3389/fmed.2023.1248912. eCollection 2023.
Front Med (Lausanne). 2023.
PMID: 37608832
Free PMC article.
Review.
Building a Better Approach for the Benefit of Patients: 10 Pillars to Strengthen Regulatory Review Systems Globally.
O'Brien J, Lumsden RS, Diehl DH, Macdonald JC.
O'Brien J, et al.
Ther Innov Regul Sci. 2020 Mar;54(2):283-292. doi: 10.1007/s43441-019-00055-9. Epub 2020 Jan 6.
Ther Innov Regul Sci. 2020.
PMID: 32072580
Review.
Item in Clipboard
Establishing a core dossier for multiple regulatory submissions: a case study in the Latin America region.
Alvarez AL, Maisonet IO, Ruiz O, Lumsden RS, Ferreira APE, Avila Flores EM.
Alvarez AL, et al. Among authors: lumsden rs.
Front Med (Lausanne). 2023 May 16;10:1102452. doi: 10.3389/fmed.2023.1102452. eCollection 2023.
Front Med (Lausanne). 2023.
PMID: 37261120
Free PMC article.
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Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities.
Ingram B, Lumsden RS, Radosavljevic A, Kobryn C.
Ingram B, et al. Among authors: lumsden rs.
Pharmaceuticals (Basel). 2021 Apr 1;14(4):306. doi: 10.3390/ph14040306.
Pharmaceuticals (Basel). 2021.
PMID: 33915725
Free PMC article.
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