Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals.

Autor: Mooghali M; Department of Internal Medicine, Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Yale Collaboration for Regulatory Rigor, Integrity and Transparency (CRRIT), Yale School of Medicine, New Haven, Connecticut., Mohammad A; Icahn School of Medicine at Mount Sinai, New York, New York., Wallach JD; Yale Collaboration for Regulatory Rigor, Integrity and Transparency (CRRIT), Yale School of Medicine, New Haven, Connecticut.; Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia., Mitchell AP; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York., Ross JS; Department of Internal Medicine, Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Yale Collaboration for Regulatory Rigor, Integrity and Transparency (CRRIT), Yale School of Medicine, New Haven, Connecticut.; Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, Connecticut., Ramachandran R; Department of Internal Medicine, Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Yale Collaboration for Regulatory Rigor, Integrity and Transparency (CRRIT), Yale School of Medicine, New Haven, Connecticut.
Jazyk: angličtina
Zdroj: JAMA network open [JAMA Netw Open] 2024 May 01; Vol. 7 (5), pp. e249233. Date of Electronic Publication: 2024 May 01.
DOI: 10.1001/jamanetworkopen.2024.9233
Databáze: MEDLINE