FDA letter monthly archive

FDA Letters Issued in August 2020

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

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

CRLComplete Response Letter
Complete Response Letter Nobelpharma Co., Ltd. (Aug 13, 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.
IssuedAug 13, 2020
US FDA• HYFTOR
CRLComplete Response Letter
Complete Response Letter DBV Technologies S.A. (Aug 3, 2020)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Device constituent and human factors, Safety and adverse events, Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 3, 2020
US FDA• FDA-regulated product

Complete Response Letter Nobelpharma Co., Ltd. (Aug 13, 2020)

Complete Response Letter DBV Technologies S.A. (Aug 3, 2020)