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Paperback New Drug Applications Book

ISBN: 1521386528

ISBN13: 9781521386521

New Drug Applications

THIS CASEBOOK contains a selection of U. S. Court of Appeals decisions that analyze, discuss and resolve patent disputes stemming from New Drug Applications filed with the Food and Drug Administration. The selection of decisions spans from 2014 to the date of publication.The Food, Drug, and Cosmetic Act ("FDCA") regulates the marketing and sale of prescription drugs in the United States. Under the FDCA, a manufacturer must obtain approval from the...

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