CRLComplete Response Letter
Complete Response Letter RedHill Biopharma Ltd. (Jan 31, 2014)
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.
Issued
US FDA• RIZAFILM
