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correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
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47 - If we offer samples to physicians, by a 3rd party company, do we need to get PAAB approval of the offer/promotion if it only contains an graphic/image of the brand name, logo, and quantity of samples offered. There will be no claims made...only this minimal information. Does a PI need to accompany the offer?
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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