Back to On-demand Webcast: PDUFA VI is Coming and the Patient Voice Will Be Front and Center in the Approval and Value Process. Are You Ready?
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On-demand Webcast: PDUFA VI is Coming and the Patient Voice Will Be Front and Center in the Approval and Value Process. Are You Ready?

An on-demand recording of the 3D Communications Sponsored Webcast, PDUFA VI is Coming and the Patient Voice Will Be Front and Center in the Approval and Value Process. Are You Ready?, originally recorded on 12 April 2017.


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With the implementation of PDUFA VI, the FDA is setting into motion a series of regulatory actions that will guide the future of drug development – and ultimately the success of approval and market access.

A key area of focus is making sure patients are involved in the overall...

Back to On-demand Webcast: PDUFA VI is Coming and the Patient Voice Will Be Front and Center in the Approval and Value Process. Are You Ready?
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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design