FDA letter monthly archive

FDA Letters in June 2020

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

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

CRLComplete Response Letter
Complete Response Letter Heron Therapeutics, Inc. (Jun 26, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence, 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.
IssuedJun 26, 2020
US FDA• ZYNRELEF KIT
CRLComplete Response Letter
Complete Response Letter Esteve Pharmaceuticals, S.A. (Jun 15, 2020)
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, 2020
US FDA• SEGLENTIS

Complete Response Letter Heron Therapeutics, Inc. (Jun 26, 2020)

Complete Response Letter Esteve Pharmaceuticals, S.A. (Jun 15, 2020)