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Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States

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 obligation...

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Pubblicato in:Milbank Q
Autori principali: SALCHER‐KONRAD, MAXIMILIAN, NACI, HUSEYIN, DAVIS, COURTNEY
Natura: Artigo
Lingua:Inglês
Pubblicazione: John Wiley and Sons Inc. 2020
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Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC7772660/
https://ncbi.nlm.nih.gov/pubmed/33021339
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/1468-0009.12476
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