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FDA letter monthly archive

FDA Letters Issued in April 2024

Browse FDA approval and complete response letters issued in April 2024. Each result links to a structured letter page with source PDF access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter

Complete Response Letter BLA 761187 (Apr 19, 2024)

This FDA letter, pertaining to Biologics License Application (BLA) 761187, outlines deficiencies and requirements for the applicant to address. It covers aspects of prescription drug labeling, carton and container labeling, proprietary name resubmission, and a comprehensive safety update. The letter also provides instructions for resubmission and notes that the product cannot be marketed until approved.

IssuedApr 19, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761376 (Apr 19, 2024)

This document is a Complete Response Letter (CRL) from the FDA regarding Biologics License Application (BLA) 761376. It outlines deficiencies that prevent approval and provides instructions for resubmission, including requirements for a safety update, proprietary name resubmission, and labeling considerations. Several sections detailing product quality, microbiology, drug substance, and drug product deficiencies are redacted.

IssuedApr 19, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218762 (Apr 17, 2024)

This section serves as an attestation for an electronic record, confirming it was signed electronically and providing details of the electronic signature, including the date, time, and a reference ID.

IssuedApr 17, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761356 (Apr 12, 2024)

This document is a deficiency letter from the FDA regarding Biologics License Application (BLA) 761356, outlining specific requirements and recommendations for its resubmission. It addresses deficiencies related to facility inspections, prescribing information, proprietary name, and a comprehensive safety update.

IssuedApr 12, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761147 (Apr 5, 2024)

This section provides feedback from the FDA regarding a Biologics License Application (BLA 761147), specifically addressing proposed labeling, proprietary name, and the requirement for a safety update. It encourages the applicant to review relevant FDA resources and guidance documents.

IssuedApr 5, 2024
US FDA• Unknown