Fralick M, Kesselheim AS - JAMA
- Commentary & Opinion
- Regulation and Clinical Evidence
Summary:
In this exchange, the manufacturer of Noctiva disputes the authors’ characterization of the clinical data and basis for FDA approval, while the authors reiterate concerns about the drug’s modest benefits relative to its serious safety risks, particularly hyponatremia in elderly patients.
VIEW SOURCE
Recent Work from PORTAL
How Congress Can Fix Expert Advisory Committees
Daval CJR, Kesselheim AS - STAT
- Commentary & Opinion
- Regulation and Clinical Evidence
International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway
Mulsant SS, Kesselheim AS, Naci H - Journal of Cancer Policy
- Research Publications
- Price, Value, and Access
- Regulation and Clinical Evidence
Comments on FDA Discussion Paper, “Considerations for the Regulation of Generative AI-Enabled Medical Devices”
Jaiswal N, Gorijavolu R, Thomas S, Hwang TJ, Celi LA, Kesselheim AS - Food and Drug Administration (FDA)
- Policy Interactions
- Regulation and Clinical Evidence
Program On Regulation, Therapeutics, And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women's Hospital • Harvard Medical School
41 Avenue Louis Pasteur, Suite 0B17, Boston, MA 02115
©2026 Program On Regulation, Therapeutics, And Law (PORTAL). All rights reserved.