FDA letter monthly archive

FDA Letters Issued in May 2020

Name: FDA Letters Issued in May 2020
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in May 2020. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Althera Life Sciences, LLC (May 26, 2020)
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.
IssuedMay 26, 2020
US FDA• ROSZET
CRLComplete Response Letter
Complete Response Letter Par Sterile Products, LLC (May 18, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence, Safety and adverse events, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMay 18, 2020
US FDA• MICAFUNGIN

Complete Response Letter Althera Life Sciences, LLC (May 26, 2020)

Complete Response Letter Par Sterile Products, LLC (May 18, 2020)