Please clarify the regulations regarding preparation of two or more units of Fludeoxyglucose F18 Injection from the same bulk product batch. What quality control sampling plan will be acceptable. What are the restrictions on unit dose preparation under the ANDA or NDA, and what would be an acceptable quality control sampling plan?
James Francis Lamb - Comment
This is comment on Notice
Positron Emission Tomography; Notice of Public Meeting; Request for Comments
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Public Submission Posted: 02/25/2011 ID: FDA-2011-N-0060-0002
Mar 07,2011 11:59 PM ET