Back to On-demand Webcast: Steps to Preparing for a Successful FDA Advisory Committee or Device Panel Meeting
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On-demand Webcast: Steps to Preparing for a Successful FDA Advisory Committee or Device Panel Meeting

An on-demand recording of the RAPS Webcast, The Steps to Preparing for a Successful FDA Advisory Committee or Device Panel Meeting, originally recorded on 18 May 2016.


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Presenting before an FDA Advisory Committee can be one of the most important—and most stressful—milestones in a product’s development. Good data alone is no longer enough to win approval. In today’s environment, companies must prepare a clear and persuasive presentation based on the...

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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