Issued to Clearside Biomedical, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 18, 2019Application
NDA 505b1 • 211950
Product
XIPERE
Company
Clearside Biomedical, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2023
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance, Clinical efficacy and substantial evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Clearside Biomedical, Inc. on October 18, 2019.
NDA 211950 is the application under which FDA issued this complete response letter for XIPERE to Clearside Biomedical, Inc.. It was reviewed by FDA Other. The letter is dated October 18, 2019.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.