Use of 55 PET radiotracers under approval of a Radioactive Drug Research Committee (RDRC).

ABSTRACT:

Background

In the US, EU and elsewhere, basic clinical research studies with positron emission tomography (PET) radiotracers that are generally recognized as safe and effective (GRASE) can often be conducted under institutional approval. For example, in the United States, such research is conducted under the oversight of a Radioactive Drug Research Committee (RDRC) as long as certain requirements are met. Firstly, the research must be for basic science and cannot be intended for immediate therapeutic or diagnostic purposes, or to determine the safety and effectiveness of the PET radiotracer. Secondly, the PET radiotracer must be generally recognized as safe and effective. Specifically, the mass dose to be administered must not cause any clinically detectable pharmacological effect

SUBMITTER: Jackson IM 

PROVIDER: S-EPMC7658275 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature