Complete Response Letters
Celitrion, Inc.: CT-P17
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Nov 23, 2022
At the time of your response to this CR letter, provide an update on the corrections and corrective actions the CMO has taken to address all observations.
CRL_BLA761219_20221123:p1:s24Complete Response Letter, Nov 24, 2021
Please refer to your biologics license application (BLA) dated November 24, 2020, received November 24, 2020, and your amendments, submitted under section 351(k) of the Public Health Service Act for CT-P17.
CRL_BLA761219_20211124:p1:s12During a recent inspection of the | manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.
CRL_BLA761219_20211124:p1:s16Satisfactory resolution of these deficiencies is required before this application may be approved.
CRL_BLA761219_20211124:p1:s17Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.
CRL_BLA761219_20211124:p2:s39For this purpose, first-cycle actions include approvals, complete responses, and withdrawals after filing.
CRL_BLA761219_20211124:p3:s5More Complete Response Letters
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