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Anonymous - Comment

Document ID: FDA-2009-N-0435-0003
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: October 12 2009, at 02:56 PM Eastern Daylight Time
Date Posted: October 14 2009, at 12:00 AM Eastern Standard Time
Comment Start Date: September 23 2009, at 12:00 AM Eastern Standard Time
Comment Due Date: December 22 2009, at 11:59 PM Eastern Standard Time
Tracking Number: 80a40bfc
View Document:  View as format xml

View Comment

The proposed rule is lacking in that when describing the 210/211 sections to comply with in the 820 scenario it does not list 211.160 or 211.194. Without these guiding principles there is not sufficient guidance within part 820 to describe how to test drug products in a manner consistent with the parts listed in the proposed rule (211.165, 211.166, etc).

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