FDA letter monthly archive

FDA Letters Issued in June 2022

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

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

CRLComplete Response Letter
Complete Response Letter AFT Pharmaceuticals Ltd. (Jun 30, 2022)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 30, 2022
US FDA• COMBOGESIC IV
CRLComplete Response Letter
Complete Response Letter Acer Therapeutics Inc. (Jun 15, 2022)
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.
IssuedJun 15, 2022
US FDA• OLPRUVA
CRLComplete Response Letter
Complete Response Letter Braintree Laboratories, Inc. (Jun 6, 2022)
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.
IssuedJun 6, 2022
US FDA• SUFLAVE

Complete Response Letter AFT Pharmaceuticals Ltd. (Jun 30, 2022)

Complete Response Letter Acer Therapeutics Inc. (Jun 15, 2022)

Complete Response Letter Braintree Laboratories, Inc. (Jun 6, 2022)