Blog | Veristat Insightful Perspectives

Regulatory TOPRA Webinar: Latest Regulatory Experiences

 

Regulatory TOPRA Webinar: Expediting Access to Novel/Medicinal Products in the US and EU Replay

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Is it Possible to Gain Regulatory Approval Following a Single-Arm Study?

In this case study example - yes.

Veristat developed a thorough regulatory submission strategy and novel efficacy endpoint for the treatment of an ultra-rare and aggressive hematologic malignancy that led to FDA and EMA approval following a single-arm phase I/II study.

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