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85 - Could you please confirm for me whether or not a Dear Doctor letter outlining a Nursing Assessment program needs PAAB approval. The program is being run by a 3rd-party. The letter does not contain any information about product and it outlines the parameters of the program itself (i.e. # of patients needed to be recruited, length of day, etc.) The Dear Doctor letter is being left with the doctor and it is being delivered and signed by the representative.
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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