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325 - Good morning, regarding a patient care program related to a specific drug that pharmacists can participate in to support their patients, does a document communicating: what the program is about, including that it's for patients diagnosed with illness A and prescribed Drug A (no claims or any other info about the drug) how the program benefits the patient how to enroll Does qualify as a document requiring PAAB approval? Thank you very much in advance.
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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