Quality By Design Pilot Analysis of FDA Regulatory Guidance Web Data Usability for Innovators in Non-Hodgkin Lymphoma: Overcoming Challenges to CAR-T Development

Background: Non-Hodgkin lymphoma (NHL) remains a challenging hematological disease due to varied presentation and etiologies. Historically, cell/gene therapy guidance from the U.S. Food and Drug Administration (FDA) have partial utility in CAR-T development owing to the unique nature of cell-based g...

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Veröffentlicht in:	Blood 2023-11, Vol.142 (Supplement 1), p.7169-7169
Hauptverfasser:	Johnson, Angela N, Wang, Limin, Boucher, Susan, Fulgoni, Arthur
Format:	Artikel
Sprache:	eng
Online-Zugang:	Volltext
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