FDA letter monthly archive

FDA Letters Issued in December 2021

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

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

CRLComplete Response Letter
Complete Response Letter Therakind Limited (Dec 22, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, 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.
IssuedDec 22, 2021
US FDA• JYLAMVO
CRLComplete Response Letter
Complete Response Letter Eli Lilly and Company (Dec 17, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 17, 2021
US FDA• REZVOGLAR
CRLComplete Response Letter
Complete Response Letter Takeda Pharmaceuticals U.S.A., Inc. (Dec 17, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 17, 2021
US FDA• EOHILIA
CRLComplete Response Letter
Complete Response Letter Eli Lilly and Company (Dec 17, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 17, 2021
US FDA• REZVOGLAR

Complete Response Letter Therakind Limited (Dec 22, 2021)

Complete Response Letter Eli Lilly and Company (Dec 17, 2021)

Complete Response Letter Takeda Pharmaceuticals U.S.A., Inc. (Dec 17, 2021)

Complete Response Letter Eli Lilly and Company (Dec 17, 2021)