Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics

Alissa K Wong; Maryam Mooghali; Reshma Ramachandran; Joseph S Ross; Joshua D Wallach

doi:10.1001/jamanetworkopen.2023.31753

Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics

JAMA Netw Open. 2023 Aug 1;6(8):e2331753. doi: 10.1001/jamanetworkopen.2023.31753.

Authors

Alissa K Wong¹, Maryam Mooghali^{1

2}, Reshma Ramachandran^{1

2}, Joseph S Ross^{1

2

3

4}, Joshua D Wallach⁵

Affiliations

¹ Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
² Yale Collaboration for Regulatory Rigor, Integrity and Transparency, Yale School of Medicine, New Haven, Connecticut.
³ Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.
⁴ Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, Connecticut.
⁵ Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.

No abstract available

Plain language summary

This cross-sectional study evaluates the duration between application to US Food and Drug Administration (FDA) and approval for new drugs and biologics in the US from 2015 to 2022.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Plain language summary

Publication types

Grants and funding