As the CDISC Industry Team Lead and as members of the CDISC SEND CBER Team, Charles River Laboratories would like to announce, as of July 15, 2020, the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) has released a Federal Register Notice announcing the requirement of support of CDISC Standard for the Exchange of Nonclinical Data (SEND).
What does this mean?
This simply means that SEND has been added to the FDA Data Standards Catalog. SEND will be required in studies that start 24 months after the transition date of March 15, 2021. Therefore, studies that start March 15, 2023 or later must be submitted to CBER using SEND.
It is encouraged that sponsors and/or applicants begin using this standard immediately.
How is this different from the original set of SEND standards?
SEND guidelines and standards have been required through the FDA Center for Drug Evaluation and Research (CDER) since 2016. The development of a biologic can be quite different from that of a small molecule drug compound. More and more every day, we see biologics being developed by biotechnology and pharmaceutical companies. The acceptance of the SENDIG v3.1 SEND dataset packages by the FDA CBER division is a positive development to further streamline the review and approval of newly developed biologics.
Is Charles River fully prepared to develop SEND datasets required by CBER and the FDA?
Simply, Yes. Over the past 13 years since SEND’s inception in 2007, our SEND experts are dedicated to providing the necessary datasets by the dates they are requested. Even though the FDA CBER requirements do not go into full effect until 2023, we are prepared to complete these datasets for clients. In the last 12 months, our SEND team successfully delivered 3,368 SEND datasets to clients.
Additional SEND Resources Available
- CDISC SEND
- Study Data Technical Conformance Guide and Data Standards Catalog
- Electronic Common Technical Document (eCTD) and Technical Rejection Criteria
- SEND Questions Answered