Following the completion of all three phases of clinical study development, a company analyses all of the data and files an NDA with the U.S. Food and Drug Administration if the data successfully demonstrate both safety and effectiveness. The NDA contains all the scientific information that the company has gathered on the investigational drug. NDAs typically run 100,000 pages or more and can take up to a year or longer to review by the FDA, on average. Once FDA approves an NDA, the new medicine becomes available for physicians to prescribe. In Europe this is referred to as the Marketing Authorisation Application (MAA) and in Japan this is the Japanese New Drug Application (JNDA)
Non-Interventional Study
Non-Interventional Study is one where: One or more approved products are prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a study protocol, but falls within current practice. The prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients (for example additional blood samples, additional visit to the investigators, additional scan). A NIS observes only daily practice, Epidemiological methods shall be used for the analysis of collected data.
