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60 - Can you please provide some clarity on the criteria regarding co-sponsorship with a physician/patient/nurse/pharmacist group(s) that would allow for PAAB exemption? That is, what criteria make one group more or less acceptable from a PAAB perspective? To clarify, if a pharma company wishes to sponsor the development of and work with an organization to supply patients with information on a particular disease state/condition in an unbranded piece how does PAAB judge whether this would/would not be exempt from pre-clearance.
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The criteria for PAAB review exemption are clearly stated in section 1.5 of the PAAB Code. For this case, the materials would need to be independently controlled and prepared without company involvement. If the materials are intended to be used by healthcare professionals for patient counseling and distributed by the company, it would be subject to the PAAB review. Please note that while it may be exempt from the PAAB review, the material may still be considered 'advertising' under the Food and Drugs Act.
