USA – FDA sets deadline for study data technical rejection criteria

The US Food and Drug Administration (FDA) has set a deadline for when it will begin refusing to file or to receive electronic submissions that fail to meet the agency’s established electronic common technical document (eCTD) validation criteria.

Beginning 15 September 2021, FDA says it will “reject submissions that contain any high validation errors included in the [technical rejection criteria] TRC.” The new effective date for the technical rejection criteria was announced in a Federal Register notice scheduled for publication on 29 July. The technical rejection criteria are applicable to submissions to both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).