US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019

Meera M Dhodapkar; Joseph S Ross; Reshma Ramachandran

doi:10.1001/jamanetworkopen.2023.18889

US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019

JAMA Netw Open. 2023 Jun 1;6(6):e2318889. doi: 10.1001/jamanetworkopen.2023.18889.

Authors

Meera M Dhodapkar¹, Joseph S Ross^{2

3

4

5}, Reshma Ramachandran^{2

4}

Affiliations

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

No abstract available

Plain language summary

This cross-sectional study examines US Food and Drug Administration regulatory review time of supplemental new indication approvals of drugs and biologics between 2017 and 2019.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Biological Factors
Biological Products* / therapeutic use
Drug Approval
Humans
Pharmaceutical Preparations
United States
United States Food and Drug Administration

Substances

Pharmaceutical Preparations
Biological Products
Biological Factors

Grants and funding

UL1 TR001863/TR/NCATS NIH HHS/United States