709 - For a product with two different administration formats (eg. syringe and pen), is it permissible to only advertise one format in APS (with no mention of the other device)?
Jennifer Carroll last edited by
Similar to AskPAAB 704, there are a number of scenarios which could result in either requiring both administration formats to be included in the APS, or allowing the focus on just one. These would depend on both the content in the TMA and the claims which are being made in the APS. For example, if the piece is promoting an indication in which the product is administered using the pen, then the selective promotion of administration with the syringe would be questioned. As the answer to this question is dependant on the specific TMA and the claims made in the APS, we suggest submitting this to PAAB as an opinion request.