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 1729-1740 of 1819 letters

WLWarning Letter
Warning Letter Diasol, Inc. (Jan 29, 2026)
FDA issued a warning letter to Diasol, Inc. concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJan 29, 2026
US FDA• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
ALApproval Letter
Approval Letter GLAUKOS (Jan 28, 2026)
FDA posted an approval letter for IDOSE TR on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218010 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 28, 2026
US FDA• IDOSE TR
ALApproval Letter
Approval Letter JAZZ PHARMS THERAP (Jan 28, 2026)
FDA posted an approval letter for VYXEOS on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209401 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 28, 2026
US FDA• VYXEOS
ALApproval Letter
Approval Letter GENZYME CORP (Jan 28, 2026)
FDA posted an approval letter for CAPRELSA on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022405 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 28, 2026
US FDA• CAPRELSA
ALApproval Letter
Approval Letter SANOFI AVENTIS US (Jan 28, 2026)
FDA posted an approval letter for PRIFTIN on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021024 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 28, 2026
US FDA• PRIFTIN
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Jan 28, 2026)
FDA posted an approval letter for DARZALEX FASPRO on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761145 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 28, 2026
US FDA• DARZALEX FASPRO
ALApproval Letter
Approval Letter GLAUKOS (Jan 28, 2026)
FDA posted an approval letter for IDOSE TR on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218010 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 28, 2026
US FDA• IDOSE TR
WLWarning Letter
Warning Letter Beta Bionics, Inc. (Jan 28, 2026)
FDA issued a warning letter to Beta Bionics, Inc. 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.
IssuedJan 28, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
ALApproval Letter
Approval Letter SCHERING (Jan 27, 2026)
FDA posted an approval letter for NOXAFIL, NOXAFIL POWDERMIX KIT on 2026-01-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022003, NDA 205053, NDA 205596, NDA 214770 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 27, 2026
US FDA• NOXAFIL / NOXAFIL POWDERMIX KIT
ALApproval Letter
Approval Letter SOLUBIOMIX (Jan 27, 2026)
FDA posted an approval letter for QUIOFIC on 2026-01-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216395 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 27, 2026
US FDA• QUIOFIC
ALApproval Letter
Approval Letter AVION PHARMS (Jan 27, 2026)
FDA posted an approval letter for PONSTEL on 2026-01-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 015034 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 27, 2026
US FDA• PONSTEL
WLWarning Letter
Warning Letter Flextronics America LLC (Jan 27, 2026)
FDA issued a warning letter to Flextronics America LLC concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Medical device quality and reporting, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJan 27, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated

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Warning Letter Diasol, Inc. (Jan 29, 2026)

Approval Letter GLAUKOS (Jan 28, 2026)

Approval Letter JAZZ PHARMS THERAP (Jan 28, 2026)

Approval Letter GENZYME CORP (Jan 28, 2026)

Approval Letter SANOFI AVENTIS US (Jan 28, 2026)

Approval Letter JANSSEN BIOTECH (Jan 28, 2026)

Approval Letter GLAUKOS (Jan 28, 2026)

Warning Letter Beta Bionics, Inc. (Jan 28, 2026)

Approval Letter SCHERING (Jan 27, 2026)

Approval Letter SOLUBIOMIX (Jan 27, 2026)

Approval Letter AVION PHARMS (Jan 27, 2026)

Warning Letter Flextronics America LLC (Jan 27, 2026)