CDER Announces Dates for eSubmissions

Federal Register notice: CDER is announcing the date that support will begin for version 1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide (SENDIG–DART) and version 1.6 of the CDISC Study Data Tabulation Model (SDTM) and the dates when such new standard and version update will be required in certain submissions. Support for version 1.1 of the CDISC SENDIG–DART and version 1.6 of the CDISC SDTM will begin 3/15. The requirement for electronic submissions to be submitted using version 1.1 of the CDISC SENDIG–DART will begin 3/15/2023, for NDAs, ANDAs and certain BLAs, and 3/15/2024 for certain INDs. The requirement for electronic submissions to be submitted using version 1.6 of the CDISC SDTM will begin on 3/15/2022. To view the notice, click here.