FDA letter monthly archive

FDA Letters Issued in September 2023

Name: FDA Letters Issued in September 2023
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in September 2023. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Galderma R&D, LLC (Sep 29, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 29, 2023
US FDA• BLA 761311
CRLComplete Response Letter
Complete Response Letter Eli Lilly and Company (Sep 28, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 28, 2023
US FDA• EBGLYSS
CRLComplete Response Letter
Complete Response Letter Botanix SB Inc. (Sep 22, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 22, 2023
US FDA• SOFDRA
CRLComplete Response Letter
Complete Response Letter ARS Pharmaceuticals, Inc. (Sep 19, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 19, 2023
US FDA• NEFFY

Complete Response Letter Galderma R&D, LLC (Sep 29, 2023)

Complete Response Letter Eli Lilly and Company (Sep 28, 2023)

Complete Response Letter Botanix SB Inc. (Sep 22, 2023)

Complete Response Letter ARS Pharmaceuticals, Inc. (Sep 19, 2023)