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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 73-84 of 291 letters

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
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218524 (Mar 29, 2024)

This FDA letter communicates deficiencies in New Drug Application (NDA) 218524, primarily concerning prescribing information (PI) and safety updates. It outlines specific requirements for revising labeling, submitting safety data, and the process for resubmission or other actions within one year.

IssuedMar 29, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218408 (Mar 27, 2024)

This FDA letter addresses deficiencies in New Drug Application (NDA) 218408, specifically regarding prescribing information, carton and container labeling, and safety updates. It outlines requirements for resubmission and emphasizes that the product cannot be marketed until approved.

IssuedMar 27, 2024
US FDA• Unknown Product
CRLComplete Response Letter

Complete Response Letter BLA 761357 (Mar 26, 2024)

This letter from the FDA addresses deficiencies in a Biologics License Application (BLA 761357) and outlines requirements for its resubmission. It covers facility inspections, prescribing information, proprietary name, and a detailed safety update, emphasizing that the product cannot be marketed until approved.

IssuedMar 26, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 7613031 (Mar 22, 2024)

This letter from the FDA identifies deficiencies in a Biologics License Application (BLA) for a product intended for follicular lymphoma, specifically regarding the timely completion of confirmatory trials. It outlines requirements for resubmission, including addressing trial progress, updating prescribing information and safety data, and resubmitting the proprietary name. The letter also provides instructions for the format and content of the resubmission and sets a one-year deadline for action.

IssuedMar 22, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 7613032 (Mar 22, 2024)

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding deficiencies found in their Biologics License Application (BLA) 761303/Original 2. It outlines specific requirements for addressing issues related to clinical trial completion, prescribing information, proprietary name, and safety updates, which must be fulfilled for a successful resubmission. The letter also provides guidance on the resubmission process and timelines.

IssuedMar 22, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 210168 (Mar 22, 2024)

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 210168. It outlines the required actions for the applicant to take within one year, primarily focusing on resubmission or other actions under 21 CFR 314.110, and details the proper format and content for a resubmission. It also mentions the option to request a meeting with the FDA.

IssuedMar 22, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218223 (Mar 8, 2024)

This document from the U.S. Food and Drug Administration (FDA) outlines significant deficiencies in New Drug Application (NDA) 218223 for GA Depot as a treatment for relapsing forms of multiple sclerosis (RMS). The FDA found the Phase 3 trial (Study Mapi GA Depot Phase III – 001) did not provide interpretable or persuasive efficacy findings, failed to establish an adequate scientific bridge to Copaxone, and exhibited numerous issues with trial design, data quality, and reliability. Furthermore, the submitted safety data were deemed inadequate, and the study raised new safety concerns, including severe injection site reactions and systemic injection-related reactions, suggesting important differences from Copaxone.

IssuedMar 8, 2024
US FDA• GA Depot
CRLComplete Response Letter

Complete Response Letter NDA 505b1 215749 (Mar 7, 2024)

This letter from the FDA outlines deficiencies in NDA 215749, primarily focusing on the requirement for a comprehensive safety update and instructions for resubmission. It details specific data and documentation needed for the safety update, including new and combined safety data, adverse event comparisons, and worldwide safety experience. The letter also sets a one-year deadline for resubmission or other actions and provides guidance on the format and content of a resubmission.

IssuedMar 7, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 217002 (Feb 26, 2024)

The FDA has identified several deficiencies in the New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia. Key issues include insufficient evidence for efficacy from Study C07, lack of data on co-administration with antipsychotics, unproven clinical meaningfulness of the observed effect on negative symptoms, and inadequate long-term safety data. Additionally, the proposed strategy for mitigating QTc prolongation risk based on CYP2D6 genotyping is deemed insufficient, requiring a robust companion diagnostic device. The FDA requires the submission of additional studies and data to address these deficiencies before the application can be approved.

IssuedFeb 26, 2024
US FDA• roluperidone
CRLComplete Response Letter

Complete Response Letter NDA 505b1 217556 (Feb 22, 2024)

This document is an FDA letter regarding New Drug Application (NDA) 217556 for cefepime for injection and taniborbactam for injection. It outlines specific deficiencies and requirements that must be addressed for the application to be approved, including detailed instructions for presenting safety data, clinical pharmacology analyses, and resubmission procedures.

IssuedFeb 22, 2024
US FDA• cefepime for injection and taniborbactam for injection, co-packaged for intravenous use
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218470 (Jan 30, 2024)

This FDA letter acknowledges receipt of a draft labeling for NDA 218470 and reserves further comment until the application is otherwise adequate. It provides detailed instructions for a required safety update, outlines specific data presentation requirements for adverse events and clinical trial information, and sets a one-year deadline for resubmission or other actions under 21 CFR 314.110. The letter also specifies formatting for resubmissions and states that the product cannot be marketed until approved.

IssuedJan 30, 2024
US FDA• Unknown

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