Definition of Generic Drug

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Generic Drug

The term 'Generic Drug' as it applies to the area of the U.S. Food and Drug Administration can be defined as ' A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. The FDA bases evaluations of substitutability, or 'therapeutic equivalence,' of generic drugs on scientific evaluations. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Drug products evaluated as 'therapeutically equivalent' can be expected to have equal effect and no difference when substituted for the brand name 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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