The FDA has issued final guidance on “Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing.'' As of June 1, 2009, FDA will only accept electronic submissions of drug establishment registration and drug listing information, unless a waiver is granted. This document provides guidance to manufacturers, repackers, and relabelers on the types of information to include for purposes of drug establishment registration and drug listing and on how to prepare and submit the information in an electronic format that FDA can process, review, and archive.
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FDA guidance on drug establishment registration and drug listing submissions in electronic format
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