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Regulatory agilities impacting review timelines for Pfizer/BioNTech's BNT162b2 mRNA COVID-19 vaccine: a retrospective study.
Patel P, Macdonald JC, Boobalan J, Marsden M, Rizzi R, Zenon M, Ren J, Chu H, Cappelleri JC, Roychoudhury S, O'Brien J, Izaki-Lee K, Boyce D. Patel P, et al. Among authors: ren j. Front Med (Lausanne). 2023 Nov 8;10:1275817. doi: 10.3389/fmed.2023.1275817. eCollection 2023. Front Med (Lausanne). 2023. PMID: 38020129 Free PMC article.
Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.
Pe M, Alanya A, Falk RS, Amdal CD, Bjordal K, Chang J, Cislo P, Coens C, Dirven L, Speck RM, Fitzgerald K, Galinsky J, Giesinger JM, Holzner B, Le Cessie S, O'Connor D, Oliver K, Pawar V, Quinten C, Schlichting M, Ren J, Roychoudhury S, Taphoorn MJB, Velikova G, Wintner LM, Griebsch I, Bottomley A; SISAQOL-IMI Consortium. Pe M, et al. Among authors: ren j. Lancet Oncol. 2023 Jun;24(6):e270-e283. doi: 10.1016/S1470-2045(23)00157-2. Lancet Oncol. 2023. PMID: 37269858 Free article. Review.
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