Positron Emission Tomography; Notice of Public Meeting; Request for Comments

Resumo

The Food and Drug Administration (FDA) is announcing a public meeting to assist applicants in preparing new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for fludeoxyglucose (FDG) 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in positron emission tomography (PET) imaging. By December 12, 2011, FDA expects all producers of PET drugs in commercial clinical use to submit applications for marketing approval. FDA recognizes that many PET drug producers are unfamiliar with the drug approval process. Accordingly, FDA is holding this public meeting to discuss the drug approval process and FDA's general inspection process. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a revised draft guidance for industry entitled "PET Drug Applications--Content and Format for NDAs and ANDAs" that will be used at the meeting to explain the drug approval process.