FDA letter monthly archive

FDA Letters Issued in May 2017

Name: FDA Letters Issued in May 2017
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in May 2017. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter TherapeuticsMD, Inc. (May 5, 2017)
FDA's complete response letter contains source-text evidence related to Safety and adverse events, Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMay 5, 2017
US FDA• IMVEXXY

Complete Response Letter TherapeuticsMD, Inc. (May 5, 2017)