Definition of Approval History

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TeachMeFinance.com - explain Approval History



Approval History

The term 'Approval History' as it applies to the area of the U.S. Food and Drug Administration can be defined as ' The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product'.

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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".


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