FDA letter monthly archive

FDA Letters Issued in November 2021

Name: FDA Letters Issued in November 2021
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in November 2021. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Fennec Pharmaceuticals, Inc. (Nov 26, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 26, 2021
US FDA• PEDMARK
CRLComplete Response Letter
Complete Response Letter Celitrion, Inc. (Nov 24, 2021)
FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 24, 2021
US FDA• YUFLYMA
CRLComplete Response Letter
Complete Response Letter Bio-Thera Solutions Ltd. (Nov 19, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 19, 2021
US FDA• AVZIVI
CRLComplete Response Letter
Complete Response Letter Santen, Inc. (Nov 9, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 9, 2021
US FDA• OMLONTI

Complete Response Letter Fennec Pharmaceuticals, Inc. (Nov 26, 2021)

Complete Response Letter Celitrion, Inc. (Nov 24, 2021)

Complete Response Letter Bio-Thera Solutions Ltd. (Nov 19, 2021)

Complete Response Letter Santen, Inc. (Nov 9, 2021)