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An insider's perspective on FDA approval of aducanumab
INTRODUCTION: Aducanumab was approved in 2021 by the US Food and Drug Administration (FDA) under the accelerated approval pathway. Since then, there have been many misconceptions about the approval decision despite multiple publications from the FDA to explain the rationale. METHODS: Even though the...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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John Wiley and Sons Inc.
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10193636/ https://www.ncbi.nlm.nih.gov/pubmed/37215506 http://dx.doi.org/10.1002/trc2.12382 |