Webinar: Tuesday, January 21, 2020 | 11:00 CST

Tuesday, Jan 21, 2020 11:00 AM – 12:00 PM CST

US First-in-Man Regulatory Requirements: Nuts and Bolts for CMC Preparation

Presenter: Sally W. Schwarz, RPh, MS, BCNP
Professor of Radiology
Co-Director Cyclotron Facility
Washington University School of Medicine


In the US, human administration of research and investigational radiopharmaceuticals (RPs) is subject to FDA regulations. One of the following mechanisms must be used for human research involving RPs—1. Approval of the application by the sponsoring institution’s Radioactive Drug Research Committee or 2. Submission of an Investigational New Drug (IND) or an exploratory IND to the FDA. This presentation will focus on the requirements for the IND/eIND Chemistry Manufacturing and Controls section and will describe the format needed for the submission. Additionally, it will briefly discuss the dosimetry and toxicology requirements.

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