FDA letter monthly archive

FDA Letters Issued in August 2021

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

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

CRLComplete Response Letter
Complete Response Letter CellTrans Inc. (Aug 18, 2021)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 18, 2021
US FDA• FDA-regulated product
CRLComplete Response Letter
Complete Response Letter Kashiv BioSciences, LLC (Aug 11, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 11, 2021
US FDA• FYLNETRA
CRLComplete Response Letter
Complete Response Letter LLC (Aug 5, 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.
IssuedAug 5, 2021
US FDA• LIQREV
CRLComplete Response Letter
Complete Response Letter Spectrum Pharmaceuticals, Inc. (Aug 3, 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.
IssuedAug 3, 2021
US FDA• ROLVEDON
CRLComplete Response Letter
Complete Response Letter Kashiv BioSciences, LLC (Aug 2, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 2, 2021
US FDA• RELEUKO

Complete Response Letter CellTrans Inc. (Aug 18, 2021)

Complete Response Letter Kashiv BioSciences, LLC (Aug 11, 2021)

Complete Response Letter LLC (Aug 5, 2021)

Complete Response Letter Spectrum Pharmaceuticals, Inc. (Aug 3, 2021)

Complete Response Letter Kashiv BioSciences, LLC (Aug 2, 2021)