In the article “Assessment of Tumoricidal Efficacy and Response to Treatment with 18F-FDG PET/CT After Intraarterial Infusion with the Antiglycolytic Agent 3-Bromopyruvate in the VX2 Model of Liver Tumor,” by Liapi et al. (J Nucl Med. 2011;52:225–230), an acknowledgment of support from the Abdulrahman A. Abdulmalik Research Fund was inadvertently omitted. The authors regret the omission.
In the article “SNM Practice Guideline for Sodium 18F-Fluoride PET/CT Bone Scans 1.0,” by Segall et al. (J Nucl Med. 2010;51:1813–1820), the first paragraph of Section III, Definitions, incorrectly states that no applications for an Investigational New Drug have been filed with the U.S. Food and Drug Administration for 18F. The corrected paragraph is shown below. The authors regret the error.
18F is a diagnostic molecular imaging agent used for identification of new bone formation. 18F, administered as intravenous Na18F, was approved by the U.S. Food and Drug Administration in 1972 but has been listed as a discontinued drug since 1984. In 2000, the Food and Drug Administration listed it in the Orange Book for discontinued drug products. The original approval in 1972 may be used as a basis to reapply for marketing approval via a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Several clinical trials are currently using Na18F with Investigational New Drug exemptions. In December 2008, the National Cancer Institute filed an NDA for a different potency and dose from the original NDA. Presently, Na18F is manufactured and distributed for clinical use by authorized user prescription under state laws of pharmacy. In December 2011, Na18F for clinical use will have to be prepared under an NDA or ANDA and meet the cGMP requirements of 21 CFR 212.
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