Back to On-demand Webcast: Effective Medical Device Pre-Sub Interactions
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On-demand Webcast: Effective Medical Device Pre-Sub Interactions

An on-demand recording of the RAPS Webcast, Effective Medical Device Pre-Sub Interactions, originally recorded on 4 May 2016.


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Congratulations – you have a new, cutting edge device. Your next steps for getting approval, clearance or clinical studies are key. Having an informal meeting with the FDA’s Pre-Sub program will help you achieve this. If you have never submitted a Pre-Sub, this webcast will teach...

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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