The Food and Drug Administration (FDA) has made the materials from the March 2, 2011 public meeting available on their website.
FDA held a public meeting on March 2, 2011, to assist applicants in preparing NDAs or ANDAs for fludeoxyglucose (FDG) 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging. By December 12, 2011, FDA expects all producers of PET drugs in commercial clinical use will begin submitting applications for marketing approval. FDA recognizes that many PET producers are unfamiliar with the drug approval process. Accordingly, FDA offered the meeting to discuss the drug approval process including drug registration and listing for PET producers and the general inspection process.
CLICK HERE to visit the FDA webpage with the meeting presentations.
CLICK HERE to view the meeting transcript.