FDA letter monthly archive

FDA Letters Issued in July 2017

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

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

CRLComplete Response Letter
Complete Response Letter Ironshore Pharmaceuticals & Development, Inc. (Jul 28, 2017)
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, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 28, 2017
US FDA• JORNAY PM
CRLComplete Response Letter
Complete Response Letter Amgen Inc. (Jul 13, 2017)
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. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 13, 2017
US FDA• EVENITY
CRLComplete Response Letter
Complete Response Letter Ocular Therapeutix, Inc. (Jul 10, 2017)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 10, 2017
US FDA• DEXTENZA

Complete Response Letter Ironshore Pharmaceuticals & Development, Inc. (Jul 28, 2017)

Complete Response Letter Amgen Inc. (Jul 13, 2017)

Complete Response Letter Ocular Therapeutix, Inc. (Jul 10, 2017)