FDA LETTER LIBRARY

FDA application & warning letters

Name: FDA Approval, Complete Response & Warning Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

Review 1,819 source-backed approval, tentative approval, complete response, and warning letters. Application letters cover 2026; the CRL corpus is complete as published by openFDA, and warning letters cover 2026.

Showing 1237-1248 of 1819 letters

ALApproval Letter
Approval Letter DAIICHI SANKYO (May 1, 2026)
FDA posted an approval letter for ENHERTU on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761139 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 1, 2026
US FDA• ENHERTU
ALApproval Letter
Approval Letter BRISTOL-MYERS (May 1, 2026)
FDA posted an approval letter for THALOMID on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020785 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 1, 2026
US FDA• THALOMID
ALApproval Letter
Approval Letter BRISTOL MYERS SQUIBB (May 1, 2026)
FDA posted an approval letter for REVLIMID on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021880 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 1, 2026
US FDA• REVLIMID
ALApproval Letter
Approval Letter PFIZER IRELAND PHARMACEUTICALS (May 1, 2026)
FDA posted an approval letter for NGENLA on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761184 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 1, 2026
US FDA• NGENLA
ALApproval Letter
Approval Letter BRISTOL (May 1, 2026)
FDA posted an approval letter for POMALYST on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204026 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 1, 2026
US FDA• POMALYST
WLWarning Letter
Warning Letter Harbin Jixianglong Biotech Co., Ltd. (May 1, 2026)
FDA issued a warning letter to Harbin Jixianglong Biotech Co., Ltd. concerning CGMP/API/Adulterated and Misbranded Drugs. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 1, 2026
US FDA• CGMP/API/Adulterated and Misbranded Drugs
WLWarning Letter
Warning Letter kadobarofficial.com (May 1, 2026)
FDA issued a warning letter to kadobarofficial.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 1, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter swisschlz.com (May 1, 2026)
FDA issued a warning letter to swisschlz.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 1, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
ALApproval Letter
Approval Letter SAMSUNG BIOEPIS CO LTD (Apr 30, 2026)
FDA posted an approval letter for EPYSQLI on 2026-04-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761340 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 30, 2026
US FDA• EPYSQLI
ALApproval Letter
Approval Letter AMGEN INC (Apr 30, 2026)
FDA posted an approval letter for PAVBLU on 2026-04-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761298 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 30, 2026
US FDA• PAVBLU
WLWarning Letter
Warning Letter CareFusion 213, LLC (Apr 30, 2026)
FDA issued a warning letter to CareFusion 213, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Laboratory controls and testing, Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedApr 30, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter ZOLL Medical Corporation (Apr 30, 2026)
FDA issued a warning letter to ZOLL Medical Corporation concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedApr 30, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated

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Approval Letter DAIICHI SANKYO (May 1, 2026)

Approval Letter BRISTOL-MYERS (May 1, 2026)

Approval Letter BRISTOL MYERS SQUIBB (May 1, 2026)

Approval Letter PFIZER IRELAND PHARMACEUTICALS (May 1, 2026)

Approval Letter BRISTOL (May 1, 2026)

Warning Letter Harbin Jixianglong Biotech Co., Ltd. (May 1, 2026)

Warning Letter kadobarofficial.com (May 1, 2026)

Warning Letter swisschlz.com (May 1, 2026)

Approval Letter SAMSUNG BIOEPIS CO LTD (Apr 30, 2026)

Approval Letter AMGEN INC (Apr 30, 2026)

Warning Letter CareFusion 213, LLC (Apr 30, 2026)

Warning Letter ZOLL Medical Corporation (Apr 30, 2026)