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Special FeaturesLast update October 8, 2019

Ask PAAB

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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

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303
According to the PAAB Guidance on Base Fair Balance Level Selection and Placement, the indication statement is not a 'claim' that requires fair balance. Therefore if an APS contained only the Drug name (including active ingredient and dosage form) and the indication statment, and no other explicit or implicit claims, would this APS require any fair balance? Would it be exempt from preclearance?
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