FDA letter monthly archive

FDA Letters Issued in March 2019

Name: FDA Letters Issued in March 2019
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in March 2019. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Proximagen, LLC (Mar 29, 2019)
FDA's complete response letter contains source-text evidence related to Device constituent and human factors, 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 29, 2019
US FDA• NAYZILAM
CRLComplete Response Letter
Complete Response Letter Fera Pharmaceuticals, LLC (Mar 28, 2019)
FDA issued a complete response letter. No controlled deficiency theme met the deterministic text-matching threshold; review the exact redacted letter.
IssuedMar 28, 2019
US FDA• AVACLYR
CRLComplete Response Letter
Complete Response Letter Sedor Pharmaceuticals, LLC (Mar 22, 2019)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 22, 2019
US FDA• SESQUIENT
CRLComplete Response Letter
Complete Response Letter Recro Pharma Inc. (Mar 22, 2019)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Bioequivalence and pharmacokinetics, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMar 22, 2019
US FDA• ANJESO

Complete Response Letter Proximagen, LLC (Mar 29, 2019)

Complete Response Letter Fera Pharmaceuticals, LLC (Mar 28, 2019)

Complete Response Letter Sedor Pharmaceuticals, LLC (Mar 22, 2019)

Complete Response Letter Recro Pharma Inc. (Mar 22, 2019)