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# CDER Expecting eCTD Data Submissions in May
- URL: https://www.fdaweb.com/cder-expecting-ectd-data-submissions-in-may/
- Published: 2017-02-15T12:00:00.000Z
- Updated: 2026-09-14T22:06:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137993

CDER is reminding industry that beginning 5/5 drug sponsors must submit applications for new drugs, generic drugs, biologics, biosimilars, and drug master files in the Electronic Common Technical Document (eCTD) format. Submissions in the eCTD format are intended to enhance the quality and efficiency of regulatory reviews. Such formatted data are required for studies started after 12/17/2016\. Guidance and associated documents are available at [Study Data Standards for Submission to CDER](http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm248635.htm?ref=fdaweb.com).