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1 - If a fax were to be sent to physicians stating only the study name (I.e. ABC), what disease area it was studying (i.e. CHD mortality) and the major results (i.e. decreased mortality) but there was no drug mention; but provided a website for the study and a 1-800 number for further information, would this require approval? What if name of the study included both drugs that were compared (i.e. Alefacept Benzoperoxide Comparison)?
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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Yes, the fax is "advertising" as interpreted by the PAAB Code because you are linking information to the web-site that is drug specific. The purpose appears to be to promote the sale of a particular drug. We note that if the product monograph did not include claims such as CHD mortality, you would be violating federal advertising law. You should not cite a study name that includes a claim that is not within the stated drug's authorized Product Monograph. When in doubt, telephone the PAAB and ask a reviewer your question.
