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484 - What happens when a piece which contains information on multiple drugs is already approved by PAAB but then a product monograph update comes out for one or more of the drugs. Does this require revision and re-submission or is the piece still valid for the duration of the approval period?
• Jennifer Carroll -
420 - What are the requirements for display signs at a conference? The display sign contains pictures of drug products and contains general information about the product. Would fair balance need to be applied to this display? Are we required to include the indications on the display? This sign would only be used at conferences along with brochures which contain the indications and fair balance information.
• Jennifer Carroll -
345 - In light of the new Fair Balance requirements (high level), are we required to include all the laboratory monitoring as part of the warnings and precautions section? It seems like a lot of info given that they are monitoring guidance but not warnings per se (e.g. monitor leucocytes very 4 weeks ...). Please advise.
• Jennifer Carroll -
344 - Hi Patrick, Lately PAAB has been requesting that the indication for a product be placed on the front page of every piece. If we are not making any clinical claims on a front page of a piece, why can we not include the indication on the second page of a piece? Your PAAB code clearly says: 2.10.2 - PAAB code, The TMA content, "Drug X is indicated for" (or equivalent) must be presented verbatim at least once within the advertising message of the APS. Nowhere does it say it has to be on the front page.....thanks!
• Jennifer Carroll -
342 - In the development of booth promotional materials intended to reprise indications, contraindications, warning and precautions which are part of the Product Monograph, are there any restrictions on how these sections can be excerpted. Is is permissible to exclude text from the indications section, for example?
• Jennifer Carroll -
272 - We are developing a patient-directed instructional guide on how to use an injectable medication. The format is a flip chart, with visual instructions on one side (for the patient), and more detailed instructions on the reverse side (for the nurse's eyes only). Given the new PAAB code, and the fact that this is a HCP-delivered patient APS based on Section III of the product monograph, would the lowest level of fair balance suffice?
• Jennifer Carroll