Valerie Fauvelle - Comment

Although FDA attempts to define the scope – it should be clearer that it relates to combination products that have different regulations that need to be taken into account and not simply drug –drug combinations – it is presented but not very clearly that is their intent. Although in the background they state the combination product is subject primarily to the requirements associated with the MAA – further text suggests that despite this you have to take account of device, drug or biological rules so this is misleading Overall – if we have to take account of such multi faceted requirements a clearer approach would be to take the most conservative of a drug device combination, drug-biological combination , Device biological combination etc and define reporting requirements Given that such multiple obligations exist there is complexity too in where the reports should go to – while reference is made to a lead centre – how the MAH know their obligations have been met opposite the other centres or divisions is unclear and an MAH may feel obliged to submit reports to device and drug divisions for example