Combination Products (Drugs, Devices and Biologics) – Part 1

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Description:

This course will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory submission process, clinical trials, and manufacturing and GMP considerations. In addition, we’ll provide links to more in-depth information on certain topics as we move through the course. An additional goal of this course is to provide an understanding and overview of the variety of regulatory and review challenges presented by combination products as compared with single-entity products.

Curriculum for this course:

Introduction

Course Overview	1 min 01 secs
Learning Objectives	1 min
Who Should Take This Course?	1 min 20 secs
Terms Explained	1 min 15 secs
Course Modules	58 secs

Module 1: Introduction to Combination Products

Overview	1 min 05 sec
Definitions	1 min 10 secs
Biological Products	48 secs
Drugs	1 min 10 secs
Devices	55 secs
Primary Mode of Action (PMOA)	1 min 24 secs
What is a Combination Product?	1 min 30 secs
Combination Product Types	1 min 10 secs
What is a Non-Combination Product?	1 min 05 sec

Module 2: Regulation of Combination Products

Office of Combination Products (OCP)	1 min 12 secs
Classification and Jurisdiction Assignment of FDA Lead Centers	1 mins 29 secs
Resolving Classification Questions	1 min 02 secs
Classification / Jurisdiction Assignment Application Process	1 min 25 secs
Pre-Request for Designation (Pre-RFD)	1 mins 11 secs
(Pre-RFD) Timelines	1 min 38 secs
Request for Designation (RFD)	1 mins 23 secs
Acts, Rules and Regulations	1 min 11 secs
Guidance Documents for Combination Products	1 min 24 secs