FDA letter monthly archive

FDA Letters Issued in June 2017

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

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

CRLComplete Response Letter
Complete Response Letter Coherus BioSciences, Inc. (Jun 9, 2017)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Statistical analysis, Clinical efficacy and substantial evidence, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 9, 2017
US FDA• UDENYCA
CRLComplete Response Letter
Complete Response Letter United Therapeutics Corporation (Jun 2, 2017)
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.
IssuedJun 2, 2017
US FDA• REMODULIN

Complete Response Letter Coherus BioSciences, Inc. (Jun 9, 2017)

Complete Response Letter United Therapeutics Corporation (Jun 2, 2017)