Theranostics: Regulatory Considerations for Product Development

July 29, 2019

In this highly attended session at the SNMMI 2019 Annual Meeting in Anaheim, California, speakers examined clinical, nonclinical and CMC information needed for theranostics product development, including a discussion on regulatory perspectives of products combining an imaging modality with therapeutic radiopharmaceuticals. The content of the session was specific to the needs of the community based on what FDA members in the medical imaging and other divisions are seeing in INDs, NDAs, aNDAs, and DMF applications filed with the agency and in other interactions with the community.

The session was sponsored by the Clinical Trials Network, the U.S. Food and Drug Administration, and the National Cancer Institute.

Click below to watch a session overview on SNMMI TV, or Download the full presentation.