704 - If a product has two possible dosing schedules, with no specific requirements/recommendations on which HCPs can choose, are we permitted to just focus on one dosing schedule in APS? If both dosing schedules are required, are we permitted to focus on one over the other in terms of prominence?
Jennifer Carroll last edited by
There are a number of scenarios which could result in either requiring both dosing schedules 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. As an example, if the piece is promoting an indication where the product is used in combination with another drug, we would question the select inclusion of a monotherapy dosing schedule. 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.