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Comments for the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee on the Galleri MCED Test

Tibau A, Hwang TJ, Kesselheim AS - Food and Drug Administration (FDA)

  • Policy Interactions
| September 2026
  • Regulation and Clinical Evidence

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How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Commentary & Opinion
| October 2026
  • 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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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

  • Research Publications
| October 2026
  • 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)

  • Policy Interactions
| October 2026
  • Regulation and Clinical Evidence
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