The Supreme Court, Preemption, and Malpractice Liability

Kesselheim AS, Studdert DM - New England Journal of Medicine

  • Regulation and Clinical Evidence

Summary:

The authors outline the Supreme Court’s ruling in Wyeth v. Levine, examining whether FDA approval of a drug’s labeling should preempt state product liability lawsuits, and discussing the implications for patient safety and manufacturer accountability.

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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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