FDA letter monthly archive

FDA Letters Issued in May 2021

Name: FDA Letters Issued in May 2021
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in May 2021. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Azurity Pharmaceuticals, Inc. (May 28, 2021)
FDA's complete response letter contains source-text evidence related to 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.
IssuedMay 28, 2021
US FDA• ZONISADE
CRLComplete Response Letter
Complete Response Letter Tanvex BioPharma USA, Inc. (May 20, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Facility inspection and CGMP compliance, Data integrity and reliability. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMay 20, 2021
US FDA• NYPOZI

Complete Response Letter Azurity Pharmaceuticals, Inc. (May 28, 2021)

Complete Response Letter Tanvex BioPharma USA, Inc. (May 20, 2021)