ABSTRACT
The Federal Food, Drug, and Cosmetic Act prohibits the shipment of a new drug into interstate commerce unless there exists an approved NDA or an effective IND application for that drug. In the European Union countries and countries that follow the EU Directives, the equivalent information that is required for a new product application is an effective Investigational Medicinal Product Dossier (IMPD). For those countries, which wish to conduct clinical research in the United States, an IND is required regardless of the proposed phase of clinical trial. Thus, even phase 1 trials to be conducted in the United States on volunteer subjects require the prior submission of an IND before that trial may be undertaken.
