Online CourseOnline Course Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective

Regulation of Combination Products [3.0 RAC]

3.0 RAC Credits Member: $365 Nonmember: $500
Regulation of Combination Products [3.0 RAC]
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 products creates several challenges in defining specific regulatory requirements because the constituent parts are regulated using different regulatory standards by different FDA centers—Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiologic Health (CDRH).

This course provides a historical perspective on combination product regulation in the US, and examines the current regulations and policies covering the identification, jurisdiction and review of combination products. It covers premarket activities, applicability of Good Manufacturing Practices (GMPs) and postmarket requirements, such as adverse event reporting, inspection and enforcement.

At a Glance
  • Target Audience: This course is designed for regulatory professionals and others in related departments interested in understanding the basics of combination product regulation in the US.
  • Learning Level: Basic
  • Total Length of Course: 3 Hours
  • RAC Points: 3

Learning Objectives

Upon completion of this course, participants should be able to:
  • Define key terminology, such as drug, device and biological product, and explain how those definitions help form the basis for the definition of a combination product
  • Describe how a primary mode of action (PMOA) is determined and its role in establishing which FDA center will have primary jurisdiction for the review of a combination product
  • Identify the type(s) and number of investigational and marketing applications that may be filed for a combination product, and the associated user fees
  • Explain the importance of, and prepare and implement a strategy for, educating, communicating and interacting with FDA throughout the regulatory process
  • Discuss some of the unique challenges of fulfilling premarket requirements for combination products and identify existing guidance and regulations in this area
  • Discuss the scope of GMP requirements for combination products
  • Describe the requirements for postmarket safety reporting for combination products
  • Discuss the inspection and enforcement of combination product requirements

Lesson Titles
  • Lesson 1: Statutory and Regulatory Background
  • Lesson 2: Product Jurisdiction
  • Lesson 3: Premarketing Activities
  • Lesson 4: Current Good Manufacturing Practices (CGMP)
  • Lesson 5: Postmarket Safety Reporting
  • Lesson 6: Special Considerations for Human Tissue Combination Products

Enrollment Period: 12 months
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