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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 13-24 of 493 letters

CRLComplete Response Letter

Complete Response Letter NDA 505b1 215644 (Jun 25, 2025)

This section outlines requirements for responding to deficiencies identified during inspections and for providing a comprehensive safety update for New Drug Application (NDA) 215644. It details specific content and formatting for the safety update, including new data integration, comparative tables, and narrative summaries for adverse events and trial discontinuations.

IssuedJun 25, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 210168 (Jun 20, 2025)

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 210168. It reserves comment on proposed labeling until the application is otherwise adequate and outlines required actions for the applicant within one year, including resubmission or withdrawal, and emphasizes that the drug cannot be marketed until approved.

IssuedJun 20, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 217382 (Jun 2, 2025)

The FDA has issued a deficiency letter for NDA 217382 concerning Nutrilipid 20%. Key issues include the lack of an adequate scientific bridge between Nutrilipid 20% and Intralipid 20% due to statistically significant physicochemical differences and insufficient data on comparable drug capture capability. The application also has deficiencies in human factors validation studies, indicating unsafe user interface for critical tasks. The FDA reserves comment on proposed labeling until other issues are resolved and requests comprehensive updates to safety data, benefit-risk assessments, and clarification on the proposed indication, especially for pediatric use and non-life-threatening Local Anesthetic Systemic Toxicity (LAST).

IssuedJun 2, 2025
US FDA• Nutrilipid 20%
CRLComplete Response Letter

Complete Response Letter NDA 505b1 219029 (May 29, 2025)

This section serves as a representation of an electronically signed record, detailing the electronic signature and associated metadata such as the signing date, time, and a reference ID.

IssuedMay 29, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 215244 (May 15, 2025)

The FDA has identified significant deficiencies in New Drug Application (NDA) 215244 for elamipretide, concluding that its effectiveness has not been established for traditional approval due to a lack of superiority over placebo in clinical trials (SPIBA-201 Part 1 & 2, SPIBA-001) and concerns regarding bias in endpoint measurements. The proposed surrogate endpoints (LVSV, MLCL:CL ratio, acylcarnitines) are also deemed insufficient for accelerated approval due to various limitations. The FDA suggests exploring muscle strength of knee extensors as a potential intermediate clinical endpoint for accelerated approval, contingent on demonstrating its predictive clinical benefit and proposing a confirmatory postmarketing trial. Additionally, the applicant must resolve facility inspection deficiencies, and address labeling and proprietary name issues.

IssuedMay 15, 2025
US FDA• elamipretide
CRLComplete Response Letter

Complete Response Letter NDA 505b1 215818 (Apr 25, 2025)

This FDA letter, dated April 25, 2025, addresses New Drug Application (NDA) 215818, outlining specific requirements and recommendations related to product quality, prescribing information, carton and container labeling, and other general submission procedures. It emphasizes the need for the applicant to address deficiencies, update various data points, and adhere to specific formatting and submission guidelines before the application can be approved and the product legally marketed.

IssuedApr 25, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218353 (Apr 25, 2025)

This FDA letter communicates deficiencies in New Drug Application (NDA) 218353 for floretyrosine F 18, requiring the applicant to address issues related to efficacy evidence, dose optimization, prescribing information, carton and container labeling, and a comprehensive safety update. It outlines specific requirements for the safety update data presentation and sets a one-year deadline for resubmission or other actions.

IssuedApr 25, 2025
US FDA• floretyrosine F 18
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218592 (Apr 25, 2025)

This document is a Complete Response Letter (CRL) from the FDA to an applicant for New Drug Application (NDA) 218592, outlining deficiencies that prevent approval and detailing the necessary actions for resubmission.

IssuedApr 25, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 216442 (Apr 2, 2025)

The FDA has identified deficiencies in NDA 216442, primarily concerning the robustness of Study 030's primary efficacy endpoint analysis and the statistical methodology used. The agency requires the applicant to conduct at least one additional adequate and well-controlled study to demonstrate positive treatment effects for ocular symptoms of dry eye, without making unapproved protocol or statistical analysis plan changes. Further comments on prescribing information, carton/container labeling, and proprietary name are reserved until the application is otherwise adequate. A safety update is also required upon resubmission, and the applicant must take action within one year to resubmit or risk withdrawal of the application.

IssuedApr 2, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218345 (Apr 2, 2025)

This FDA letter provides feedback on NDA 218345, acknowledging revised labeling and carton/container labeling submissions, but reserving further comment until the application is otherwise adequate. It outlines detailed requirements for a safety update, including specific data presentation and analysis, and provides instructions for resubmission or other actions within one year.

IssuedApr 2, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218571 (Mar 27, 2025)

This FDA letter for NDA 218571 outlines deficiencies in the application, particularly concerning labeling and safety data, and provides instructions for resubmission and further actions required for approval.

IssuedMar 27, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761377 (Mar 26, 2025)

This FDA letter outlines deficiencies and requirements for the applicant of Biologics License Application (BLA) 761377 to achieve approval. It details specific instructions for submitting revised prescribing information, carton and container labeling, proprietary name information, and a comprehensive safety update. The letter also provides guidance on the resubmission process and timelines.

IssuedMar 26, 2025
US FDA• Unknown

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