FDA letter monthly archive

FDA Letters Issued in March 2017

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

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

CRLComplete Response Letter
Complete Response Letter Institut Biochimique SA (IBSA) (Mar 24, 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, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 24, 2017
US FDA• LICART
CRLComplete Response Letter
Complete Response Letter Sun Pharma Advanced Research Company Limited (Mar 22, 2017)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 22, 2017
US FDA• ELEPSIA XR

Complete Response Letter Institut Biochimique SA (IBSA) (Mar 24, 2017)

Complete Response Letter Sun Pharma Advanced Research Company Limited (Mar 22, 2017)