FDA Indication Extrapolations-Allowing Flexibility While Providing Greater Clarity

Reshma Ramachandran^{1

2}, Joseph S Ross^{1

3

4

5}

Affiliations

¹ National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
² Veterans Affairs Connecticut Healthcare System and Yale University, West Haven, Connecticut.
³ Section of General Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
⁴ Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.
⁵ Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, Connecticut.

Free article

Comment

Reshma Ramachandran et al. JAMA Netw Open. 2022.

Free article

. 2022 Apr 1;5(4):e227961.

doi: 10.1001/jamanetworkopen.2022.7961.

Reshma Ramachandran^{1

2}, Joseph S Ross^{1

3

4

5}

¹ National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
² Veterans Affairs Connecticut Healthcare System and Yale University, West Haven, Connecticut.
³ Section of General Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
⁴ Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.
⁵ Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, Connecticut.

No abstract available

Comment on

Use of Extrapolation in New Drug Approvals by the US Food and Drug Administration.
Feldman D, Avorn J, Kesselheim AS. Feldman D, et al. JAMA Netw Open. 2022 Apr 1;5(4):e227958. doi: 10.1001/jamanetworkopen.2022.7958. JAMA Netw Open. 2022. PMID: 35438753 Free PMC article.