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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
New web-based learning course-
“Electronic Common Technical Document (eCTD): Overview and Submission”
FDA/CDER’s Small Business Assistance Program announces the launch of its first CDERLearn web-based learning courses, “Electronic Common Technical Document (eCTD): Overview and Submission.”
Learn from the source! This course will explain, with precise detail, CDER’s policies and practices regarding electronic submissions and will guide you through the appropriate steps to transition your applications (old and new) to the eCTD format. It will address the essential steps of submitting electronic submissions to CDER, and is a great resource for questions about the submission process.
We hope that you find it helpful. Additional courses will be posted on our Small Business CDERLearn page as we develop them.
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email us at druginfo@fda.hhs.gov.
- For additional drug information, please visit the DDI Web page.
- For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info
- This service is provided to you at no charge by the U.S. Food & Drug Administration (FDA).
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