FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ELECTRONIC COMMON TECHNICAL DOCUMENT; DATA STANDARDS; CENTER FOR DRUG EVALUATION AND RESEARCH AND CENTER FOR BIOLOGICS EVALUATION AND RESEARCH SUPPORTING ELECTRONIC COMMON TECHNICAL DOCUMENT VERSION 3.2.2 AND VERSION 4.0

WASHINGTON, Oct. 16 -- Food and Drug Administration has issued a notice called: Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 3.2.2 and Version 4.0.

The notice was published in the Federal Register on Oct. 16 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing the date FDA will begin rejecting electronic submissions that fail new Electronic Common Technical Document (eCTD) Version 3.22 (v...