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    The Prescription Drug User Fee Act (PDUFA): A Primer

    This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process. Introduction: Benefits Offered by PDUFA When planning a New Drug Application (NDA) or other type of marketing application, regulatory professionals must consider many things. These considerations include: when the data will com...
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    Fast Facts: Serious Adverse Event Reporting Requirements in the US

    This article presents reporting requirements for Serious Adverse Events (SAEs) and focuses on an important, but often overlooked regulation that specifies when a study is being run and includes the use of an approved drug. There are reporting requirements with specific timeframes that must be followed if there is a reportable SAE attributed to the approved drug. Adverse Events (AE) in clinical trials are considered serious adverse events when the AE meets any one of th...
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    IND Application Fast Facts

    This article provides information companies need when filing an Investigational New Drug (IND) a pplication  with the US Food and Drug Administration (FDA) to help make the application process more efficient. It addresses common questions and concerns that develop across multiple companies and multidisciplinary groups. When is there a 30-day FDA review? After filing an IND application with FDA, there is a mandatory 30-day review period. 1 The purpose of this review i...