title: The food and drug administration and molecular imaging agents: potential challenges and opportunities.
abstract: Molecular imaging, which combines the use of traditional imaging modalities with pharmaceutical and biologic imaging agents, holds considerable promise, particularly in light of recent advances in genomics and new applications beyond diagnosis toward the earlier detection and characterization of disease, the reliable assessment of treatment efficacy, and imaging-link therapeutic applications. Its potential notwithstanding, the current U.S. Food and Drug Administration (FDA) regulatory framework governing imaging agents sets a high bar for marketing approval, which may slow the pace at which molecular imaging becomes routinely available. Understanding the FDA's regulatory framework, the issues surrounding molecular imaging agents, and potential opportunities will allow the radiology community to more effectively collaborate with the FDA to address these regulatory barriers and ensure that the full potential of molecular imaging is realized.
authors.affiliation: Center for Integration of Medicine and Innovative Technology, Cambridge, MA 02139, USA. jahenderson@partners.org
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Henderson
authors.forename: Brooke C
authors.initials: BC
authors.lastname: Alexander
authors.forename: John J
authors.initials: JJ
authors.lastname: Smith
mesh_terms: D003952:Diagnostic Imaging / Q000592:standards; D017277:Drug Approval; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008967:Molecular Biology; D011877:Radionuclide Imaging / Q000592:standards*; D019275:Radiopharmaceuticals / Q000494:pharmacology* / Q000592:standards; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D019275:Radiopharmaceuticals