FDA letter monthly archive

FDA Letters Issued in June 2024

Browse FDA approval and complete response letters issued in June 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 761377 (Jun 27, 2024)

This letter from the FDA addresses deficiencies in Biologics License Application (BLA) 761377, requesting specific updates and submissions related to labeling, proprietary name, and a comprehensive safety update. It outlines the requirements for resubmission and the timeline for action.

IssuedJun 27, 2024

US FDA• Unknown

CRLComplete Response Letter

Complete Response Letter BLA 761366 (Jun 26, 2024)

This document is a Complete Response Letter (CRL) from the FDA for Biologics License Application (BLA) 761366, detailing deficiencies that must be addressed before the application can be approved. It outlines specific requirements for labeling revisions, proprietary name resubmission, and a comprehensive safety update, along with instructions for resubmission or other actions.

IssuedJun 26, 2024

US FDA• Unknown

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