New Drug Approvals in Oncology

Kurzrock R, Kantarjian HM, Kesselheim AS, Sigal EV - Nature Reviews Clinical Oncology

  • Regulation and Clinical Evidence

Summary:

This viewpoint presents a debate about the evolving regulatory paradigm for cancer drugs, with the authors arguing that newer expedited approval pathways have accelerated access to beneficial therapies and that delays in drug approval have historically cost tens of thousands of patient life-years, while acknowledging the need for rigorous evidence standards.

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International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway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