FDA letter monthly archive

FDA Letters in December 2020

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

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

CRLComplete Response Letter
Complete Response Letter InnoPharma Licensing LLC (Dec 22, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 22, 2020
US FDA• ACETAMINOPHEN
CRLComplete Response Letter
Complete Response Letter Novartis Pharmaceuticals Corporation (Dec 18, 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.
IssuedDec 18, 2020
US FDA• LEQVIO
CRLComplete Response Letter
Complete Response Letter scPharmaceuticals Services, Inc (Dec 3, 2020)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Device constituent and human factors, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 3, 2020
US FDA• FUROSCIX / FUROSCIX READYFLOW (AUTOINJECTOR)

Complete Response Letter InnoPharma Licensing LLC (Dec 22, 2020)

Complete Response Letter Novartis Pharmaceuticals Corporation (Dec 18, 2020)

Complete Response Letter scPharmaceuticals Services, Inc (Dec 3, 2020)