Providing Regulatory Submissions in e-format_Drug Listing

The Food and Drug Administration announced in a Federal Register notice of July 11, 2008, the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing.'' This draft guidance document establishes a Pilot Program for industry to voluntarily submit drug establishment registration and drug listing information in an electronic format that FDA can process, review, and archive. The document provides guidance on what required and FDA-recommended information related to drug establishment registration and drug listing to submit and on how to electronically prepare and submit the information to FDA http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-15801.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2005-N-0464-gdl.pdf.