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TeachMeFinance.com - explain New Drug Application (NDA) New Drug Application (NDA) The term 'New Drug Application (NDA) ' as it applies to the area of the U.S. Food and Drug Administration can be defined as ' When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDA's are assigned an NDA number'. Previous 5 Terms: Neutron source neutron star Neutron, thermal neutrosophy new drug application (nda) Next 5 Terms: New Drug Application (NDA) Number New field New field discoveries New Molecular Entity (NME) New reservoir About the author Mark McCracken Author: Mark McCracken is a corporate trainer and author living in Higashi Osaka, Japan. He is the author of thousands of online articles as well as the Business English textbook, "25 Business Skills in English". Copyright © 2005-2011 by Mark McCracken, All Rights Reserved. TeachMeFinance.com is an informational website, and should not be used as a substitute for professional medical, legal or financial advice. Information presented at TeachMeFinance.com is provided on an "AS-IS" basis. Please read the disclaimer for details.