Reputation and Precedent in the Bevacizumab Decision

Carpenter D, Kesselheim AS, Joffe S - New England Journal of Medicine

  • Regulation and Clinical Evidence

Summary:

The authors discuss the FDA’s decision to withdraw bevacizumab’s (Avastin) accelerated approval for metastatic breast cancer after confirmatory trials failed to show the expected benefit, arguing that the decision was appropriate and consistent with the regulatory framework for accelerated approval.

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Recent Work from PORTAL

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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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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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Politics and the Patient Encounter, in Dire Times

Avorn J - MedPage Today

  • Regulation and Clinical Evidence