FDA letter monthly archive

FDA Letters Issued in April 2016

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

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

CRLComplete Response Letter
Complete Response Letter Evofem, Inc. (Apr 28, 2016)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Safety and adverse events, Chemistry, manufacturing, and controls, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 28, 2016
US FDA• PHEXX
CRLComplete Response Letter
Complete Response Letter Camargo Pharmaceutical Services (Apr 15, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Bioequivalence and pharmacokinetics, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 15, 2016
US FDA• MYCAPSSA

Complete Response Letter Evofem, Inc. (Apr 28, 2016)

Complete Response Letter Camargo Pharmaceutical Services (Apr 15, 2016)