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Sponsored Webcast: PDUFA VI is Coming and the Patient Voice Will Be Front and Center in the Approval and Value Process. Are You Ready?
April 12, 2017
12:00 PM - 1:30 PM ET
1.50 RAC

With the implementation of PDUFA VI, become better positioned to mitigate and avoid the risk of research gaps and unanswered needs when a compound gets to Phase III.

  • List Price: Free

Wednesday, 12 April 2017
12:00-1:30pm ET

Sponsored by:

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...

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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