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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 25-36 of 291 letters

CRLComplete Response Letter

Complete Response Letter BLA 761308 (Mar 20, 2025)

This FDA letter addresses deficiencies in Biologics License Application (BLA) 761308, providing detailed instructions for revising labeling, updating safety information, and resubmitting the application. It outlines specific requirements for content, format, and timelines to achieve potential approval, emphasizing that the product cannot be marketed until written approval is received.

IssuedMar 20, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 216586 (Mar 20, 2025)

The FDA issued a Complete Response Letter (CRL) for NDA 216586 for rivoceranib tablets, indicating that the application cannot be approved in its present form due to outstanding issues, primarily concerning the co-dependent approval of SHR-1210 and labeling adequacy.

IssuedMar 20, 2025
US FDA• rivoceranib tablets
CRLComplete Response Letter

Complete Response Letter BLA 761424 (Mar 13, 2025)

This FDA letter, identified as BLA 761424, outlines deficiencies in a Biologics License Application and provides detailed instructions for resubmission. It specifies requirements for updating prescribing information (labeling) to conform with regulations and guidances, and mandates a comprehensive safety update incorporating new clinical data, worldwide experience, and foreign labeling translations.

IssuedMar 13, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761393 (Mar 11, 2025)

This document is a deficiency letter from the FDA regarding Biologics License Application (BLA) 761393. It outlines deficiencies related to product quality, prescribing information, proprietary name, and requires a comprehensive safety update upon resubmission. The letter also provides instructions for resubmission and potential next steps.

IssuedMar 11, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 217719 (Mar 10, 2025)

This section outlines the required actions for an applicant following an FDA letter regarding NDA 217719, including deadlines for resubmission or other actions, specific formatting for resubmissions, and conditions for product distribution.

IssuedMar 10, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761290 (Jan 31, 2025)

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding Biologics License Application (BLA) 761290. It outlines deficiencies and provides instructions for resubmission, including requirements for labeling, proprietary name, and a comprehensive safety update. The letter also specifies the timeline and format for resubmission and notes that the product cannot be marketed until approved.

IssuedJan 31, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 219112 (Jan 17, 2025)

This document from the U.S. Food and Drug Administration (FDA) addresses deficiencies in New Drug Application (NDA) 219112, specifically regarding proposed labeling and the requirement for a comprehensive safety update.

IssuedJan 17, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 125745 (Jan 15, 2025)

The FDA has issued a Complete Response letter for Atara Biotherapeutics, Inc.'s Biologics License Application (BLA) for tabelecleucel, indicating that final approval cannot be granted due to unresolved deficiencies related to Chemistry, Manufacturing, and Controls (CMC) and inspectional observations. The FDA reserves comment on labeling until other issues are resolved.

IssuedJan 15, 2025
US FDA• tabelecleucel
CRLComplete Response Letter

Complete Response Letter BLA 761266 (Jan 3, 2025)

This document outlines specific requirements and recommendations for a Biologics License Application (BLA) for a biosimilar product, focusing on the submission of updated safety data, labeling information, and proprietary name details. It emphasizes compliance with FDA regulations and guidance for biosimilar products.

IssuedJan 3, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218879 (Jan 3, 2025)

This FDA letter for NDA 218879 outlines deficiencies and requirements for the applicant to address in a resubmission. It details specific instructions for revising prescribing information, updating carton and container labeling, and comprehensively presenting new safety data from clinical studies and worldwide experience. The letter also sets a one-year deadline for resubmission or other actions and clarifies the process for resubmission and potential meetings.

IssuedJan 3, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 219357 (Dec 23, 2024)

This FDA letter addresses deficiencies in New Drug Application (NDA) 219357, providing instructions for the applicant to resubmit the application. Key areas of focus include labeling, proprietary name, and a comprehensive safety update, along with general resubmission requirements and timelines.

IssuedDec 23, 2024
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 210934 (Dec 20, 2024)

The FDA has issued a Complete Response Letter for NDA 210934 for sotagliflozin, indicating that the application is not approvable. The agency concluded that the submitted data did not support a favorable benefit-risk assessment for sotagliflozin in patients with Type 1 Diabetes (T1D) and eGFR ≥60 ml/min/1.73m2 and UACR ≥30 mg/g, primarily due to the risk of Diabetic Ketoacidosis (DKA) outweighing the modest glycemic and other non-glycemic benefits. The letter outlines deficiencies and suggests potential paths forward, including conducting new clinical safety trials to demonstrate adequate DKA risk mitigation and providing additional data for T1D patients with eGFR <60 ml/min/1.73m2.

IssuedDec 20, 2024
US FDA• sotagliflozin

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