Outterson K, Powers JH, Gould I, Kesselheim AS - Clinical Infectious Diseases
- Commentary & Opinion
- Regulation and Clinical Evidence
Summary:
The authors question the feasibility and cost-effectiveness of the proposal to develop 10 new antibiotics by 2020, arguing that without reforms to clinical trial design and post-approval stewardship, simply incentivizing new antibiotic development could cost billions while failing to address resistance.
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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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.