Complete Response Letters
CLASS 2 RESUBMISSION: Romidepsin
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Nov 4, 2019
Federal Food, Drug, and Cosmetic Act for Romidepsin Injection solution, 10 mg/2 mL (5 mg/mL).
CRL_NDA208574_20191104:p1:s132027158) manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.
CRL_NDA208574_20191104:p1:s19Satisfactory resolution of these deficiencies is required before this application may be approved.
CRL_NDA208574_20191104:p1:s20More Complete Response Letters
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