US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021

James L Johnston; Joseph S Ross; Reshma Ramachandran

doi:10.1001/jamainternmed.2022.6444

US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021

JAMA Intern Med. 2023 Apr 1;183(4):376-380. doi: 10.1001/jamainternmed.2022.6444.

Authors

James L Johnston¹, Joseph S Ross^{2

3

4

5}, Reshma Ramachandran^{2

4

5}

Affiliations

¹ Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
² Section of General Internal 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 National Clinician Scholars Program, Yale School of Medicine, Department of Internal Medicine, New Haven, Connecticut.
⁵ Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut.

No abstract available

Plain language summary

This cross-sectional study determines the frequency of and rationale for US Food and Drug Administration (FDA) approval of drugs not meeting pivotal trial primary efficacy end points.

Publication types

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

MeSH terms

Drug Approval*
Humans
Pharmaceutical Preparations
Research Design*
United States
United States Food and Drug Administration

Substances

Pharmaceutical Preparations

Grants and funding

UL1 TR001863/TR/NCATS NIH HHS/United States