The Investigational New Drug Application and the Investigator’s Brochure

The Federal Food, Drug and Cosmetic Act prohibits the shipment of a new drug into interstate commerce unless there exists for that drug an approved NDA or an effective IND application. Unlike certain European countries, such as Germany and the United Kingdom, the existence of 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.