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IV.
GENERAL SUBMISSION PACKAGE:
1. Based on the supporting information, were there any additional steps in the evaluation of the
method that indicated the need for any additional precautionary statements in the method?
2. Does the method contain system suitability tests or controls as specified by the SMPR? If no,
please indicate if there is a need for such tests or controls and which ones.
3. Is there information demonstrating that the method system suitability tests and controls as
specified in the SMPR worked appropriately and as expected? If no, please specify.
4. Based on the supporting information, is the method written clearly and concisely? If no, please
specify the needed revisions.
5. Based on the supporting information, what are pros/strengths of the method?