Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States
Maximilian Salcher‐Konrad; Huseyin Naci; Courtney Davis · 2020 · Milbank Quarterly
WASTE classifies this as Negative / Null Result Report · AI classification, approximate
The study found no significant effect — useful as a negative control or null benchmark for your own design.
Abstract
Policy Points Regulatory agencies may have limited evidence on the clinical benefits and harms of new drugs when deciding whether new therapeutic agents are allowed to enter the market and under which conditions, including whether approval is granted under special regulatory pathways and obligations to address knowledge gaps through postmarketing studies are imposed. In a matched comparison of marketing applications for cancer drugs of uncertain therapeutic value reviewed by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), we found frequent discordance be
Abstract by Maximilian Salcher‐Konrad; Huseyin Naci; Courtney Davis, Milbank Quarterly (2020) — licensed CC BY 4.0.
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Metadata source: OpenAlex · DOI 10.1111/1468-0009.12476