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Real-world evidence for regulatory decision-making: updated guidance from around the world.
Front Med (Lausanne). 2023 Oct 30;10:1236462. doi: 10.3389/fmed.2023.1236462. eCollection 2023.
Front Med (Lausanne). 2023.
PMID: 38020096
Free PMC article.
Review.
Real World-Evidence for Regulatory Use Decision Aid: An Interactive Tool To Inform Clinical Development and Regulatory Strategies.
Burns L, Kalesnik-Orszulak R, Spring R, Zeegers F, Rutstein M, Hukkelhoven M, Wruck L, O'Donnell J.
Burns L, et al. Among authors: kalesnik orszulak r.
Adv Ther. 2022 Oct;39(10):4772-4778. doi: 10.1007/s12325-022-02257-4. Epub 2022 Aug 16.
Adv Ther. 2022.
PMID: 35972721
Free PMC article.
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Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World.
Burns L, Roux NL, Kalesnik-Orszulak R, Christian J, Hukkelhoven M, Rockhold F, O'Donnell J.
Burns L, et al. Among authors: kalesnik orszulak r.
Clin Ther. 2022 Mar;44(3):420-437. doi: 10.1016/j.clinthera.2022.01.012. Epub 2022 Feb 15.
Clin Ther. 2022.
PMID: 35181179
Free article.
Review.
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