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James Francis Lamb - Comment

Document ID: FDA-2011-N-0060-0002
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: February 16 2011, at 12:00 AM Eastern Standard Time
Date Posted: February 25 2011, at 12:00 AM Eastern Standard Time
Comment Start Date: February 3 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: March 7 2011, at 11:59 PM Eastern Standard Time
Tracking Number: 80bf04e1
View Document:  View as format xml

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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?

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James Francis Lamb - Comment
Public Submission    Posted: 02/25/2011     ID: FDA-2011-N-0060-0002

Mar 07,2011 11:59 PM ET