Accelerating Innovation in Rapid Diagnostics and Targeted Antibacterials

Hwang TJ, Powers JH, Carpenter D, Kesselheim AS - Nature Biotechnology

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence

Summary:

Policy efforts to combat antibiotic resistance should prioritize narrow-spectrum antibiotics paired with rapid diagnostic tests. The atuhors argue that this approach could delay resistance and reduce adverse effects compared with broad-spectrum agents, and recommend a pilot regulatory pathway to facilitate their development.

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How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Regulation and Clinical Evidence
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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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

  • Price, Value, and Access
  • Regulation and Clinical Evidence
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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)

  • Regulation and Clinical Evidence