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313 - Does an indication statement constitute a therapeutic benefit/claim or efficacy statement in and of itself? If so, can you confirm that any APS with the indication statement on it would require highest level fair balance?

Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists

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Jennifer Carroll

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A piece with only the indication statement, would qualify for the lowest level fair balance. Please see the guidance document "Guidance on Generating the Three Base Fair Balance Levels" and "Guidance on Base Fair Balance Level Selection and Placement".
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