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 last edited by
The indication statement must be presented verbatim once in the APS per section 2.10 of the PAAB code. The other segments mentioned in your question need not be verbatim but they must reflect the essence of the product monograph. Please refer to the guidance documents on the PAAB website for requirements relating to fair balance format in drug advertising.