FDA letter monthly archive

FDA Letters Issued in February 2011

Name: FDA Letters Issued in February 2011
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in February 2011. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Teva Women’s Health, Inc. (Feb 28, 2011)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, 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.
IssuedFeb 28, 2011
US FDA• MILPROSA
CRLComplete Response Letter
Complete Response Letter EMD Serono, Inc. (Feb 28, 2011)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, 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.
IssuedFeb 28, 2011
US FDA• MAVENCLAD

Complete Response Letter Teva Women’s Health, Inc. (Feb 28, 2011)

Complete Response Letter EMD Serono, Inc. (Feb 28, 2011)