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3.00 RAC

Regulation of Combination Products

This course provides an overview of combination product regulation in the US, including premarket activities, applicability of Good Manufacturing Practices (GMPs) and postmarket requirements.

3.00 RAC

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  • Member Price: $360.00

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Combination products have the potential to offer novel alternatives for patient care because the unique combination of drugs, medical devices and/or biological products produces therapeutic or diagnostic results not seen when such products are used independently. However, development of combination...

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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