Combination Products: How to Get a Product Through The FDA Approval Process

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Course Description 

This course provides a comprehensive approach to the preparation and submission of FDA documents for approval of combination products. Participants receive a foundation of knowledge about the combination product process, submission preparation and the underlying scientific and regulatory principles involved. 

Participants will gain knowledge about the FDA Office of Combination Products, the combination product process, request for designation submission, primary mode of action determination and the entire combination product system. 

Learning Objectives 

  • Describe what combination products are 
  • Navigate the Office of Combination Products 
  • Describe primary mode of action determination 
  • Understand the combination products process 
  • Understand Request for Designation submissions 

Who Should Attend

This course is intended for Regulatory, Clinical, Research, Quality, Manufacturing and other personnel who require an in-depth knowledge of the FDA combination product process. 


Albert A. Ghignone, M.S., R.A.C. 

Click here for complete trainer biographies

Course Outline 

Day 1: 8:30 a.m. – 5:00 p.m. 

  • FDA History, Laws, regulations, policies and Guidances 
  • FDA Definitions 
  • What are Combination Products: Drug/Biologic; Drug/Device; Biologic/Device; Other 
  • FDA Office of Combination Products: History; Organization; Responsibilities 
  • Combination Products Acts, Rules and Regulations: Food and Drug Act; 21 CFR  

Day 2: 8:30 a.m. – 5:00 p.m. 

  • Primary Mode of Action: Definition; Examples 
  • Request for Designation Submission: Information in a RFD; Comprehensive review of all RFD sections 
  • Primary Jurisdiction: CDER; CBER, CDRH 
  • General Questions About Combination Products: Questions 
  • Guidance Douments for Combination Products: Guidance Documents 

There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day. 

Interactive Activities 

  • Review scenarios and identify solutions 
Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day. 

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings. 

Click here for our seminar cancellation policy 

Accreditation Information

ACPE LogoBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-12-087-L01-P. Released: 9/12. 

Hold this course at your company! 

For more information, contact Naila Ganatra at (215) 413-2471. 


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On-Demand GCP Refresher Training 

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GCP for Investigators

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 

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