FDA letter monthly archive

FDA Letters Issued in December 2018

Name: FDA Letters Issued in December 2018
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in December 2018. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter International Medication Systems, Limited (Dec 12, 2018)
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, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 12, 2018
US FDA• EPINEPHRINE

Complete Response Letter International Medication Systems, Limited (Dec 12, 2018)