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FDA LETTER LIBRARY

Complete response & enforcement letters

One place to review FDA responses, identify remediation themes, and open the interactive co-pilot for every letter.

Showing 61-72 of 291 letters

CRLComplete Response Letter

Complete Response Letter BLA 125806 (Jun 14, 2024)

This is a Complete Response Letter from the FDA to Rocket Pharmaceuticals, Inc. regarding their Biologics License Application (BLA) for marnetegragene autotemcel. The FDA has concluded that they cannot grant final approval due to deficiencies, primarily in Chemistry, Manufacturing, and Controls (CMC), and also reserves comment on labeling until the application is otherwise acceptable. The letter outlines requirements for resubmission and options for discussion.

IssuedJun 14, 2024
US FDA• marnetegragene autotemcel
CRLComplete Response Letter

Complete Response Letter NDA 505b1 217379 (Jun 14, 2024)

This document outlines the requirements for submitting a safety update as part of a New Drug Application (NDA) response, detailing specific data presentation and analysis expectations for nonclinical and clinical studies.

IssuedJun 14, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218506 (Jun 13, 2024)

This document is a Complete Response Letter (CRL) from the FDA for New Drug Application (NDA) 218506, outlining deficiencies that prevent approval in its current form. It addresses issues related to product quality, proprietary name, facility inspections, and requires a comprehensive safety update.

IssuedJun 13, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218698 (Jun 12, 2024)

This FDA letter communicates deficiencies in New Drug Application (NDA) 218698, reserving comment on proposed labeling until the application is otherwise adequate. It outlines specific requirements for a safety update, details for resubmission, and options for meeting requests.

IssuedJun 12, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218317 (May 24, 2024)

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 218317. It outlines deficiencies identified during the review process, particularly concerning facility inspections, safety updates, and labeling, and provides instructions for a complete response and resubmission.

IssuedMay 24, 2024
US FDA• Engolce
CRLComplete Response Letter

Complete Response Letter BLA 761308 (May 16, 2024)

This document is a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) to an applicant regarding Biologics License Application (BLA) 761308. It outlines deficiencies found in the application and specifies additional information and actions required for potential approval, particularly focusing on safety data, clinical trial information, and administrative procedures for resubmission.

IssuedMay 16, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 216586 (May 16, 2024)

This document outlines requirements for New Drug Application (NDA) submissions, specifically regarding the resubmission of a proprietary name and the provision of a comprehensive safety update when responding to application deficiencies. The safety update must include detailed data from all nonclinical and clinical studies, incorporating new findings, retabulated adverse event frequencies, and narrative summaries for serious events or deaths.

IssuedMay 16, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 216987 (May 10, 2024)

This document is a letter from the FDA regarding New Drug Application (NDA) 216987, outlining deficiencies that need to be addressed before approval. It specifies requirements for labeling revisions, a comprehensive safety update, and procedures for resubmission or other actions.

IssuedMay 10, 2024
US FDA• Unknown
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

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