In This Section
CTN Webinars
"There’s a New PET Drug in Town: Manufacturing and Approval Considerations for Your Institution"
Organized by the SNMMI Clinical Trials Network
Speaker: David W. Dick, PhD
Date: May 7, 2020 at 3:00 pm ET
Fee: Complimentary
NDAs for new imaging agents, submitted by universities, have been approved recently and the universities have waived exclusivity rights. Would you like to use these new agents at your site? Learn the regulatory mechanisms that can be used (IND, ANDA, cost recovery, expanded access) to make these agents available to your patients. Have your staff – including your regulatory manager – register for this informative and helpful webinar.
Learning Objectives
- Describe the difference of using approved drugs under IND or ANDA.
- Explain the requirements for cost recovery and expanded access INDs.
- Understand the review timelines for ANDA approval.