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TeachMeFinance.com - explain Abbreviated New Drug Application (ANDA) Abbreviated New Drug Application (ANDA) The term 'Abbreviated New Drug Application (ANDA)' as it applies to the area of the U.S. Food and Drug Administration can be defined as ' An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called 'abbreviated' because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public'. Previous 5 Terms: AB ABA abampere Abandoned wells abbatial Next 5 Terms: Abbreviated New Drug Application (ANDA) Number ABC abecedarian aberdevine Aberrant 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.