FDA Preliminary Comments for Zolbetuximab.clzb (BLA 761365) February 7, 2023 and June 15, 2020

FDA Preliminary Comments for Zolbetuximab.clzb (BLA 761365) February 7, 2023 and June 15, 2020

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Original Request: From the review of zolbetuximab.clzb (BLA 761365), I would like to request the preliminary comments issued by FDA on February 7, 2023 from a meeting request made on December 20, 2022 and the "Type C CMC Meeting Preliminary Comments" on June 15 2020.
Tags: Pharma, BLA, 2023
  • 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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