FDA letter monthly archive

FDA Letters Issued in December 2019

Name: FDA Letters Issued in December 2019
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in December 2019. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter ViiV Healthcare Company (Dec 19, 2019)
FDA's complete response letter contains source-text evidence related to 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 19, 2019
US FDA• CABENUVA KIT / VOCABRIA
CRLComplete Response Letter
Complete Response Letter Takeda Pharmaceuticals, U.S.A., Inc. (Dec 17, 2019)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, 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 17, 2019
US FDA• ENTYVIO

Complete Response Letter ViiV Healthcare Company (Dec 19, 2019)

Complete Response Letter Takeda Pharmaceuticals, U.S.A., Inc. (Dec 17, 2019)