Theranostics 2013; 3(11):885-893. doi:10.7150/thno.5513
Bringing New PET Drugs to Clinical Practice - A Regulatory Perspective
Division of Nuclear Medicine, Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
Hung JC. Bringing New PET Drugs to Clinical Practice - A Regulatory Perspective. Theranostics 2013; 3(11):885-893. doi:10.7150/thno.5513. Available from http://www.thno.org/v03p0885.htm
The regulatory framework for radioactive drugs, in particular those used in positron emission tomography (PET) scans, has been gradually established since the release of the Food and Drug Administration Modernization Act in 1997. Various guidances specially tailored to accommodate special properties of PET drugs have been issued by the Food and Drug Administration (FDA) in order to ensure this valuable technology (i.e., PET molecular imaging) will continue to be available to patients and yet the safety and efficacy of PET drugs are well regulated so that public health will be protected. This article presents several key elements of this regulatory framework for PET drugs. New regulatory avenues proposed by the FDA to facilitate the research and development process to bring more new PET drugs to clinical practice, as well as to foster the opportunity of using “orphan” PET drugs in clinical practice are also discussed in this paper.
Keywords: PET drugs, FDA, regulations, RDRC, IND, NDA, exploratory IND, expanded access IND.