FDA drafts guidance on alternate electronic formats, announces support for new data standards
The FDA on Tuesday issued draft guidance detailing an alternate electronic format for submissions that qualify for an exemption or waiver from electronic common technical document (eCTD) requirements.
The guidance comes less than a month after the FDA finalized the seventh revision to its guidance on making regulatory submissions in eCTD format to denote when an exemption or waiver from eCTD requirements is warranted.
According to that guidance, Type III drug master files (DMFs) and noncommercial investigational new drug applications (INDs) are exempted from eCTD requirements, while certain positron emission tomography (PET) drugs and Type II DMFs for PET drugs may qualify for a long-term waiver from eCTD requirements. In some “unique and rare” circumstances, such as natural disasters or malware attacks, the FDA says it may grant short-term waivers for other submissions.
In the new seven-page draft guidance, the FDA details how to submit applications and other regulatory submissions in alternate electronic format, without extensible markup language (xml) backbone.
The FDA explains that “although the alternate electronic format utilizes the same folder structure found in eCTD submissions, it does not include xml and other specific files needed for electronic display [and] does not require specialized software.”
The guidance goes on to describe the folder structure of the alternate electronic format and provides recommendations to sponsors that plan to make submissions using the format.
The FDA says the guidance applies to submissions and applications that are exempted or received a waiver from eCTD requirements, including new drug applications (NDAs) and abbreviated new drug applications (ANDAs), as well as certain DMFs, INDs and biologics license applications (BLAs).
The FDA also announced Tuesday that it will begin supporting the use of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model version 1.8 (SDTM v1.8) and Standard for Exchange of Nonclinical Data Implementation Guide—Animal Rule version 1.0 (SENDIG-AR v1.0) standards on 15 March.
Both standards will be required in submissions to the agency as of 15 March 2022. The FDA says it will update its data standards catalog to reflect the use of the new standards shortly.
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.