What are the data requirements of drug registration in USA?

Essentials of Pharmacology for Health Professions
7th Edition
ISBN:9781305441620
Author:WOODROW
Publisher:WOODROW
ChapterCRE1: Comprehensive Review Exam For Part 1
Section: Chapter Questions
Problem 1CEP1
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What are the data requirements of drug registration in USA?  Please answer at your own easy words.  Answer should be to the point. 

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