FDA Study Data Must Follow CDISC Versions Listed in Its Data Standards Catalog

Section 745A(a) of the Federal Food, Drug, and Cosmetic Act provides that submissions under NDAs, ANDAs, BLAs and INDs must be in the electronic format specified in FDA guidance. FDA’s guidance Providing Regulatory Submissions in Electronic Format: Standardized Study Data, issued in December 2014 and updated in June 2021, uses this authority to require standardised study data.

According to FDA material, sponsors must conform to the standards in the FDA Data Standards Catalog for NDA, BLA and ANDA studies that started after 17 December 2016, and for commercial IND studies that started after 17 December 2017. The Catalog lists which versions of each standard FDA supports and, where relevant, the dates from which support begins and older versions end. For clinical data this means CDISC SDTM and ADaM, for nonclinical data CDISC SEND, together with Define-XML for metadata and CDISC controlled terminology.

The Study Data Technical Conformance Guide explains how to apply these standards in practice. It limits the terms SDTM, ADaM and SEND to the versions that FDA lists in the Catalog, so a new CDISC release does not automatically become acceptable on publication.

The Catalog is not limited to study data. It also specifies the supported versions of other electronic submission standards. FDA’s Federal Register notice of 16 October 2026 on eCTD v4.0 forward compatibility, for example, states that the version of eCTD currently supported by FDA is specified in the Catalog. For sponsors, this makes the Catalog the single reference point for checking which versions of submission and data standards are accepted on a given date, and the Federal Register the place where changes to it are announced.

FDA updated the Technical Conformance Guide in 2026. A version labelled 6.2 and dated March 2026 is published on the HHS guidance portal, and FDA’s guidance listing shows a 2026 final version of the document under docket FDA-2014-D-0092. Secondary sources describe updates to the define.xml and Study Data Reviewer’s Guide sections. Sponsors should use the version currently linked from FDA’s guidance page.

An FDA guidance document records that on 6 May 2025 FDA published a Federal Register notice announcing support for a version update and updated the Catalog, with a transition date of 15 March 2026. The snippet seen for this brief did not identify the standard concerned; secondary sources link the update to newer SDTM, SDTMIG, ADaM and Define-XML versions, which should be checked against the Catalog itself. Separately, CDISC lists Define-XML version 2.1.11, dated 6 April 2026, as its latest release, but sponsors should use only the Define-XML version that the Catalog lists.

For nonclinical data, FDA announced in March 2024 support for the CDISC SEND Implementation Guide for Animal Rule studies, version 1.0, with support beginning on 26 March 2024 and a requirement for studies starting after 15 March 2027 in NDAs, ANDAs and certain BLAs and INDs.

SAS XPORT version 5 remains the specified transport format for clinical and nonclinical datasets. On 9 April 2025 FDA published a Federal Register notice requesting comment on CDISC Dataset-JSON version 1.1 as a possible replacement (docket FDA-2025-N-0129). Trade reports from May 2026 state that FDA, CDISC and PHUSE had completed preliminary testing and that CBER and CDER planned further testing.

At the time of checking, Dataset-JSON had not been added to the Catalog as a supported exchange format, and no support or requirement date had been announced. Any move would be announced through the Catalog and the Federal Register, so sponsors should not submit Dataset-JSON in place of XPT unless FDA says it may be used.

Submissions that do not meet the standards can be refused at the technical stage. FDA’s technical rejection criteria set out the validations that apply, and the eCTD validations in those criteria took effect on 15 September 2021. One frequently cited rule is the requirement for a trial summary dataset (ts.xpt) for each study in the relevant sections of the submission.

Programming and data management teams should check the Catalog before locking the data standards for each study, record the versions used in the study data reviewer’s guides, and monitor Federal Register notices for new support and end dates. FDA data standards activity in 2026 also covered safety reporting: from 1 October 2026, postmarketing individual case safety reports for drugs and biologics must use the ICH E2B(R3) standard, with E2B(R2) accepted through 30 September 2026.