The meaning of SEND and its importance

SEND (Standard for Exchange of Nonclinical Data, non-clinical data exchange standard) is defined and maintained by the SEND team of the Clinical Data Inter-change Standards Consortium (CDISC). SEND is a method for collecting and presenting nonclinical data and is one of the required standards for submitting data to the FDA.

SEND Importance

According to the requirements of the US FDA, after December 17, 2016, applications for general toxicity tests (including single and multiple dose general toxicity tests) and carcinogenicity tests for NDA, ANDA, and BLA must be submitted in accordance with the SEND format standard; 2017 After December 17, 2019, general toxicity tests (including single and multiple dose general toxicity tests) for IND applications must also use the SEND format.

Safety pharmacology trials for NDA and BLA applications conducted after March 15, 2019, and safety pharmacology trials for IND applications conducted after March 15, 2020, are also required to be submitted to the FDA in SEND format. SENDIG 3.1 contains a subset of safety pharmacology, including respiratory and cardiovascular studies.

CDISC released the SEND standard SENDIG-AR for animal regulatory studies on September 17, 2019. FDA began to support this standard after March 15, 2020. For studies initiated after March 15, 2022, animal regulatory research The SEND dataset is required when submitting to the Center for Drug Evaluation and Research (CDER), depending on the type of regulatory submission.

On March 15, 2021, SENDIG-DART v1.1 was included in the FDA catalog and is based on SEND v 3.1 for the assessment of reproductive toxicity of antineoplastic drugs (primarily embryonic development (EFD)). Antineoplastic drug reproductive toxicity studies are required to use the SEND dataset for studies expected to initiate after March 15, 2023.

[1].SEND | CDISC https://www.cdisc.org/standards/foundational/send

[2].https://www.fda.gov/drugs/news-events-human-drugs/send-cber-what-you-need-know-12042020