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.

  • The short answer is "Yes". But I think the following details will help you manage the amount of information. Only content referring to monitoring instructions which do not refer specifically to a risk already stated elsewhere in the fair balance need be included. For example, if there is already a bullet referring to risk of reduction of white blood cells, there is no need to also include an instruction to monitor white blood cells. Also note that when it comes to 'Other Relevant Warnings and Precautions' (which is the heading under which this type of info would typically need to be presented if not emphasized in the TMA), you are only required to identify the issue (in this case, the need to monitor X, Y, and Z). There is no need to describe the frequency of monitoring, the thresholds that should trigger further actions...etc.