FDA BLA 761225 Detailed Assessments – Biologics Product Area – Hugel, Inc.

FDA BLA 761225 Detailed Assessments – Biologics Product Area – Hugel, Inc.

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Original Request: Product Area: Biologics // Request Record: Detailed assessments of the BLA submission "BLA 761225" // Detail of Request: 3 Assessments (1. Assessment date is March 29, 2022, 2. Resubmission assessment date is March 31, 2023, 3. Resubmission 2 date is Feb. 21, 2024) // Company: Hugel, Inc. (FEI 3012163998)
Tags: Pharma, BLA, 2022
  • 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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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