Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals-Reference-Cited by-同舟云学术

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

Published:2024-05-01 Issue:5 Volume:7 Page:e249233
ISSN:2574-3805
Container-title:JAMA Network Open
language:en
Short-container-title:JAMA Netw Open

Author:

Mooghali Maryam¹²,Mohammad Ayman³,Wallach Joshua D.²⁴,Mitchell Aaron P.⁵,Ross Joseph S.¹²⁶⁷,Ramachandran Reshma¹²

Affiliation:

1. Department of Internal Medicine, Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut

2. Yale Collaboration for Regulatory Rigor, Integrity and Transparency (CRRIT), Yale School of Medicine, New Haven, Connecticut

3. Icahn School of Medicine at Mount Sinai, New York, New York

4. Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia

5. Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York

6. Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut

7. Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, Connecticut

Abstract

This cross-sectional study evaluates the use of the US Food and Drug Administration’s Real-Time Oncology Review (RTOR) program in confirming the effectiveness of cancer drugs.

Publisher

American Medical Association (AMA)

Link

https://jamanetwork.com/journals/jamanetworkopen/articlepdf/2818124/mooghali_2024_ld_240044_1713544698.8853.pdf

Reference6 articles.

1. U.S. Food and Drug Administration: initial experience with the Real-Time Oncology Review program.;de Claro;Clin Cancer Res,2021

2. Analysis of the Real-Time Oncology Review (RTOR) pilot program for approvals of new molecular entities.;Feng;Ther Innov Regul Sci,2021

3. Extending the US Food and Drug Administration’s postmarket authorities.;Fernandez Lynch;JAMA Health Forum,2023

4. U.S. Food and Drug Administration. Real-Time Oncology Review (RTOR) guidance for industry. Accessed January 3, 2024. https://www.fda.gov/media/173641/download

5. U.S. Food and Drug Administration. New drugs at FDA: CDER’s new molecular entities and new therapeutic biological products. Accessed January 3, 2024. https://www.fda.gov/drugs/development-approval-process-drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Clinical benefit, reimbursement outcomes, and prices of FDA-approved cancer drugs reviewed through Project Orbis in the USA, Canada, England, and Scotland: a retrospective, comparative analysis;The Lancet Oncology;2024-08

2. The US Food and Drug Administration Dual Mandate for Rapid Drug Review and Equity;JAMA Network Open;2024-05-01