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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.


Credits:
3.00 RAC

  • List Price: $495.00
  • 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