Preparing NDAs or ANDAs for fludeoxyglucose (FDG) 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging; Public Meeting
FDA is announcing a public meeting 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 is holding this public meeting to discuss the drug approval process including drug registration and listing for PET producers and the general inspection process.
Date: March 2, 2011
Time: 8:30 a.m. – 5:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503
Silver Spring, Maryland 20993-0002
- Agenda (PDF - 16KB)
All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking//Airport information/Nearby Hotels for the FDA White Oak Campus (PDF - 37KB) and the Map of White Oak Visitor Parking (PDF - 105KB) for further details on transportation, parking and lodging.
Attendance and Registration
The FDA Conference Center at the White Oak location is a federal facility with limited seating. Attendance is free and will be on a first come, first served basis.
If you need special accommodations because of disability, please contact Elizabeth Giaquinto, Center for Drug Evaluation and Research, Food and Drug Administration, phone (301)796-3416, e-mail PETDrugs@fda.hhs.gov at least 7 days before the meeting.
Webcast of Meeting
For those unable to attend in person, the meeting will also be webcast. Watch the webcast on March 2, 2011 8:30 am to 5:00 pm. Requirements and instructions for accessing the webcast are below.
You may access the webcast on March 2, 2010, via this link: https://collaboration.fda.gov/petdrugs/
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