» Articles » PMID: 24224621

Expediting Drug Development--the FDA's New "breakthrough Therapy" Designation

Overview
Journal N Engl J Med
Specialty General Medicine
Date 2013 Nov 15
PMID 24224621
Citations 36
Authors
Affiliations
Soon will be listed here.
Abstract

The FDA's new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies.

Citing Articles

Clinical Benefit, Price, and Regulatory Approval of Cancer Drugs Granted Breakthrough Therapy Designation in China, 2020-2024.

Luo X, Du X, Lv X, Yang Y, Zhang X, Huang L JAMA Netw Open. 2024; 7(10):e2439080.

PMID: 39412805 PMC: 11581593. DOI: 10.1001/jamanetworkopen.2024.39080.


The United States Food and Drug Administration's Platform Technology Designation to Expedite the Development of Drugs.

Niazi S Pharmaceutics. 2024; 16(7).

PMID: 39065616 PMC: 11279857. DOI: 10.3390/pharmaceutics16070918.


Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study.

Avery J, Bell J, Baryolay K, Rodin G, Nissim R, Balneaves L BMC Cancer. 2024; 24(1):373.

PMID: 38528488 PMC: 10962144. DOI: 10.1186/s12885-024-12119-7.


Decision-making as discovery: Vetting clinical research in a leading precision oncology service.

Cambrosio A, Campbell J, Drilon A, Keating P, Polk J Sociol Health Illn. 2023; 46(3):495-513.

PMID: 37796533 PMC: 11878200. DOI: 10.1111/1467-9566.13719.


The association between US Food and Drug Administration-expedited review designations and health plan specialty drug coverage.

Panzer A, Ingham M, Martin S, Chambers J J Manag Care Spec Pharm. 2023; 29(5):464-471.

PMID: 36989444 PMC: 10394180. DOI: 10.18553/jmcp.2023.22415.