Electronic Filing of Drug Registration and Listing Information: Notice of Pilot Project

概要

The Food and Drug Administration (FDA) is seeking volunteers to participate in a pilot project involving the electronic filing of drug registration and listing information, as described in FDA's regulations. Manufacturers, repackers, and relabelers who engage in the manufacture, preparation, propagation, or processing of human or veterinary drugs and human biological products are required under current regulations to submit a listing of every product in commercial distribution. This information is currently submitted in paper format. FDA is developing an electronic system for submitting the required information, and is seeking volunteers to test the pilot system.