August 1, 2016
The society has been given permission by the Food and Drug Administration to share the "Imaging Drug Development - FDA Regulatory Issues" presentation from SNMMI's 2016 Annual Meeting. The FDA sponsored session took place on Tuesday, June 14, at the San Diego Convention Center in San Diego, California. SNMMI is grateful for the opportunity to share this valuable information with members.
Educational objectives of the presentation include identifying CMC and compliance issues as they relate to research, IND, and NDA, describing DMIP product approvals and safety-related issues, discussing PET inspection issues as well as discussing FDA’s perspective on 68Ge / 68Ga Generators and 68Ga radiolabeled approved kit. Access the links below to view specific presentations.
Access the links below to view FDA's presentations.