Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program

Cheryl Ho; Howard J Lim; Dean A Regier

doi:10.1001/jamanetworkopen.2021.20301

Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program

JAMA Netw Open. 2021 Aug 2;4(8):e2120301. doi: 10.1001/jamanetworkopen.2021.20301.

Authors

Cheryl Ho^{1

2}, Howard J Lim^{1

2}, Dean A Regier^{3

4}

Affiliations

¹ Department of Medical Oncology, BC Cancer, Vancouver, British Columbia, Canada.
² Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
³ Cancer Control Research, BC Cancer, Vancouver, British Columbia, Canada.
⁴ School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.

Abstract

This quality improvement study compares US Food and Drug Administration accelerated approvals with Canadian health and technology assessment approvals and timelines for malignant hematology and oncology treatments.

Publication types

Comparative Study

MeSH terms

Antineoplastic Agents / standards*
Canada
Drug Approval / legislation & jurisprudence*
Drug Approval / statistics & numerical data*
Hematologic Neoplasms / drug therapy*
Humans
Practice Guidelines as Topic / standards*
Time Factors
United States
United States Food and Drug Administration / legislation & jurisprudence*
United States Food and Drug Administration / trends*

Substances

Antineoplastic Agents