Preparing for Mandatory Electronic Submission of Drug Establishment Registration and Drug Listing Information

Prepared by Gina A. Ross and Greg A. Onyszchuk, Ph.D.

Introduction

United States federal laws make mandatory the registration of drug establishments, including both domestic and foreign, and the submission of drug listing information to
FDA1,2,3.

Effective June 1, 2009, there are important changes to the requirements - and these changes apply to every company that has a drug establishment registration or drug listing with FDA4.

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