Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals
Overview
Overview
Journal
JAMA Netw Open
Publisher
American Medical Association
Specialty
General Medicine
Date
2024 May 1
PMID
38691363
Authors
Authors
Affiliations
Affiliations
Soon will be listed here.
References
1.
De Claro R, Gao J, Kim T, Kluetz P, Theoret M, Beaver J
. U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program. Clin Cancer Res. 2020; 27(1):11-14.
DOI: 10.1158/1078-0432.CCR-20-2220.
View
2.
Feng C, Virparia R, Mui E
. Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities. Ther Innov Regul Sci. 2021; 55(4):881-888.
PMC: 8081281.
DOI: 10.1007/s43441-021-00296-7.
View
3.
Lynch H, Sachs R, Lee S, Herder M, Ross J, Ramachandran R
. Extending the US Food and Drug Administration's Postmarket Authorities. JAMA Health Forum. 2023; 4(6):e231313.
DOI: 10.1001/jamahealthforum.2023.1313.
View