FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ELECTRONIC COMMON TECHNICAL DOCUMENT (ECTD); DATA STANDARDS; SUPPORTING FORWARD COMPATIBILITY FOR ECTD 4.0

WASHINGTON, Oct. 16 -- Food and Drug Administration has issued a notice called: Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 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 support for Forward Compatibility for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.

For more information, contact Jonathan Resnick, Center for Drug Evaluation and Research, Food and Drug Administr...