FDA letter monthly archive

FDA Letters Issued in October 2019

Name: FDA Letters Issued in October 2019
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in October 2019. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Clearside Biomedical, Inc. (Oct 18, 2019)
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.
IssuedOct 18, 2019
US FDA• XIPERE
CRLComplete Response Letter
Complete Response Letter AuroMedics Pharma LLC (Oct 1, 2019)
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.
IssuedOct 1, 2019
US FDA• CYCLOPHOSPHAMIDE

Complete Response Letter Clearside Biomedical, Inc. (Oct 18, 2019)

Complete Response Letter AuroMedics Pharma LLC (Oct 1, 2019)