Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)

ReGARDD provides academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics and medical devices.

Who We Are

The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) affiliates are comprised of regulatory affairs specialists and experts from North and South Carolina Institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. Currently these institutions are the University of North Carolina at Chapel HillDuke UniversityWake Forest School of Medicine, RTI International, the Medical University of South Carolina, University of Miami and Virginia Commonwealth University.

Combining the regulatory talents from several of the Southeast Clinical and Translational Science Awards (CTSA) Programs and the research triangle park (RTP) area enables sharing of ideas, lessons learned, historical information, and the development of successful strategies to assist the academic researcher in navigating an increasingly complex regulatory environment. 

Learning Objectives

Detailed guidance to assist in preparing and maintaining an Investigational New Drug submission.

  1. What is an IND?
  2. Is My Study Exempt?
  3. Getting Started with an Initial IND Submission
  4. FDA Responses and Meetings
  5. IND Maintenance
  6. Drug Development

Detailed guidance to assist in preparing and maintaining an Investigational Device Exemption submission.

  1. What is an IDE?
  2. Is My Study Exempt?
  3. Is My Study Significant Risk or Nonsignificant Risk?
  4. Getting Started with an Initial IDE Submission
  5. FDA Responses and Meetin
Competencies
Scientific concepts and research design
Ethical and participant safety considerations
Medicines development and regulation
ReGARDD
Level
Advanced
Fee
No
Availability
On demand
Delivery Method
Online

Submitted by Michelle Maclay on Thu, 02/27/2020 - 13:35 . Last modified on 04/15/2021