FDA letter monthly archive

FDA Letters Issued in September 2013

Name: FDA Letters Issued in September 2013
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in September 2013. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Delcath Systems, Incorporated (Sep 12, 2013)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Device constituent and human factors, Labeling, packaging, and proprietary name, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 12, 2013
US FDA• HEPZATO

Complete Response Letter Delcath Systems, Incorporated (Sep 12, 2013)