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From course:

DRUG DISCOVERY DEVELOPMENT (DDD)

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Question:

DIFFERENT FROM RX DRUGS and review is NOT HELD AS SAME STANDARDS WITH NDA 1st phase- involved ADVISORY PANEL consist of multidisciplinary group of scientists FDA review all statements and publishes tentative final monograph Final monograph is published and goes effect ONE YEAR after publication Recognized as safe, effective, NOT MISBRANDED Following the monograph, company can market OTC drug without additional approval from FDA

Author: LEIGHTON DWIGHT OBILLOS



Answer:

Over The Counter Drug Approval


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