IDE (Investigational Device Exemption)
- Journal of Clinical and Translational Science
Introduction: With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergency Use Authorizations, and Clinical Trials.
- Virginia Commonwealth UniversityMedical practitioners frequently identify clinical needs, new product ideas, and enhanced methodologies for improving diagnosis, treatment and patient care. Physicians, surgeons, nurses, engineers and others can benefit from learning about steps involved in translating their ideas and discoveries into clinical practice. In 2020 and 2021, the VCU Institute of Engineering and Medicine, the VCU
- April 09, 2021Every day, millions of people in health care, from oncologists to rehabilitation specialists to dentists, use the tools at their disposal to help patients get better. “And everyone runs into times when they say, what if?” said L. Franklin Bost, MBA. “What if I had something better? What if I could give someone better treatment? What if I could improve this patient’s health care, or many patients’
- University Of Rochester
The goal of the core training modules is to cultivate advanced understanding of research topics. Each of the ten learning modules covers a different topic area.
- University Of Michigan
This is a training module for investigators who will hold an IND or an IDE and are thus considered a sponsor-investigator under the FDA regulations. It provides information regarding the sponsor-investigator requirements of an IND or IDE and resources in order to be in compliance with FDA regulations. This module will allow you to indicate if you are using a drug or a device so that the
- Duke University
This training provides information regarding the sponsor and investigator requirements for an IND or IDE as well as resources to ensure compliance with FDA regulations. There are two separate training modules that each focus on the requirements for the specific regulatory application that the sponsor or sponsor-investigator holds. Sponsors who hold an IND (for drugs and biologics) can complete the
- University Of North Carolina Chapel HillDuke UniversityWake Forest University Health SciencesMedical University Of South CarolinaUniversity Of Miami School Of MedicineVirginia Commonwealth UniversityReGARDD 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. Investigational New Drug or Biologic Investigational Device Exemption Educational Videos ReGARDD Sponsored Events Who We Are The Regulatory Guidance for Academic Research of Drugs and