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72 - In order for a prescription to be filled for product X, the doctor must submit a form which will function as the prescription to a 3rd party distributor. the form also includes the patient's signature which allows the patient to request the 3rd party company to research the patient's insurance coverage for product x on their behalf. There are no product claims on the form (no efficacy, no safety, nothing). Only the doctor receives the form (the patient can not get it any other way then when the doctor makes the decision to Rx the drug for the patient). The drug is restricted to a very specific indication; therefore the form includes the specific diagnosis code to allow the 3rd party to ensure that the drug is no prescribed off label. The form is a strictly administrative document, the pharma company never has access to any of the specific information (no doctor names, no patient names etc...). Am I correct in my conclusion that this would not need PAAB review?
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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