Definition of RLD (Reference Listed Drug)

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TeachMeFinance.com - explain RLD (Reference Listed Drug)



RLD (Reference Listed Drug)

The term 'RLD (Reference Listed Drug) ' as it applies to the area of the U.S. Food and Drug Administration can be defined as ' A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart'.

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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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