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Drug registration guidance

This article was originally published in The Tan Sheet

Executive Summary

FDA will discontinue conventional mailing of annual re-registration forms to private label drug distributors and instead make them available online, according to draft guidance announced in May 15 Federal Register. Agency is developing software to allow electronic submission of drug registration/listing information. Until software is ready, Forms FDA 2656, 2657 and 2658 should be accessed online at www.fda.gov/cder/drls/registration_listing.htm
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