FDA Schedules Meeting for PET Drug Approval Applicants
The March 2 meeting will help applicants prepare new drug applications or abbreviated new drug applications for fludeoxyglucose 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection.
The Food and Drug Administration announced a March 2 meeting at its White Oak Campus in Silver Spring, Md., to help applicants prepare new drug applications or abbreviated new drug applications for fludeoxyglucose 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in positron emission tomography (PET) imaging. All producers of PET drugs for commercial clinical use are submitting applications for marketing approval by Dec. 12, 2011.
FDA says many PET drug makers are not familiar with the drug approval process, however, so this meeting will explain it and also FDA’s general inspection process.
Since the Food and Drug Administration Modernization Act of 1997 became law, FDA has regulated PET drugs used in nuclear medicine. In March 2000, the agency FDA presented its findings on the safety and effectiveness of the PET drugs it studied and described the types of applications that can be submitted for FDG F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging. A December 2009 regulation began a two-year timeline for PET drug producers to submit an application for any drug used clinically.
FDA also published revised draft guidance for industry about the content and format of the applications in the Feb. 3 Federal Register and will use it at the meeting to explain the approval process.
For information, contact Elizabeth Giaquinto of FDA’s Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Room 6164, Silver Spring, MD 20993-0002, 301-796-3416, fax 301-847-8752, e-mail PETDrugs@fda.hhs.gov.