FDA Humacyte BLA Review and Approval Correspondence for ATEV Product

FDA Humacyte BLA Review and Approval Correspondence for ATEV Product

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Original Request: FDA communications with Humacyte, Inc. regarding review and approval/rejection of Humacyte’s Biologics License Application for their ATEV (Acellular Tissue-Engineered Vessel) product used for vascular trauma.
Tags: Pharma, EIR, 2024
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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