FDA LETTER LIBRARY

Complete response & enforcement letters

Name: FDA Complete Response & Enforcement Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

One place to review FDA responses, identify remediation themes, and open the interactive co-pilot for every letter.

Showing 289-291 of 291 letters

ALApproval Letter
Approval Letter Other 761039 (Jan 1, 2018)
This document is a Complete Response Letter from the FDA to Coherus BioSciences, Inc. regarding their Biologics License Application (BLA) 761039 for CHS-1701. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to immunogenicity, product quality, prescribing information, proprietary name, and safety updates. The letter outlines specific issues and provides recommendations for addressing them.
IssuedJan 1, 2018
US FDA• CHS-1701
ALApproval Letter
Approval Letter Other 761088 (Jan 1, 2018)
This is a Complete Response letter from the FDA to CELLTRION, Inc. regarding their Biologics License Application (BLA) 761088 for the proposed biosimilar product CT-P10. The FDA has determined that the application cannot be approved in its current form due to deficiencies identified in facility inspections, clinical data, product quality, and other regulatory aspects. The letter outlines specific issues and provides recommendations for addressing them prior to resubmission.
IssuedJan 1, 2018
US FDA• CT-P10
ALApproval Letter
Approval Letter Other 761091 (Jan 1, 2018)
This document is a Complete Response letter from the FDA to CELLTRION, Inc. regarding their Biologics License Application (BLA) for CT-P6. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, product quality, and the need for an updated safety profile.
IssuedJan 1, 2018
US FDA• CT-P6

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Approval Letter Other 761039 (Jan 1, 2018)

Approval Letter Other 761088 (Jan 1, 2018)

Approval Letter Other 761091 (Jan 1, 2018)