FDA letter monthly archive

FDA Letters in October 2016

Name: FDA Letters in October 2016
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued or posted in October 2016. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter United Therapeutics Corporation (Oct 7, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 7, 2016
US FDA• REMODULIN

Complete Response Letter United Therapeutics Corporation (Oct 7, 2016)