FDA letter monthly archive

FDA Letters Issued in January 2022

Name: FDA Letters Issued in January 2022
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in January 2022. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Pfizer Ireland Pharmaceuticals (Jan 21, 2022)
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, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJan 21, 2022
US FDA• NGENLA

Complete Response Letter Pfizer Ireland Pharmaceuticals (Jan 21, 2022)